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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00252 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This phase Ib/II trial studies the best dose and safety of Bcl-2 inhibitor GDC-0199 in combination with obinutuzumab and ibrutinib and to see how well they work in treating patients with chronic lymphocytic leukemia that has returned (relapsed), does not respond to treatment (refractory), or is previously untreated. Bcl-2 inhibitor GDC-0199 and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may block cancer growth in different ways by targeting certain cells. Giving Bcl-2 inhibitor GDC-0199 together with obinutuzumab and ibrutinib may be a better treatment for chronic lymphocytic leukemia.
PRIMARY OBJECTIVES:
I. To identify the dose of venetoclax (Bcl-2 inhibitor GDC-0199) that can be safely administered in combination with obinutuzumab and ibrutinib for the treatment of relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL).
II. To evaluate the feasibility, safety, and tolerability of venetoclax in combination with obinutuzumab and ibrutinib in patients with relapsed/refractory or previously untreated CLL.
III. To determine the minimal residual disease (MRD)-negative complete response (CR) rate after 12 cycles of treatment with venetoclax in combination with obinutuzumab and ibrutinib in patients with relapsed/refractory or previously untreated CLL.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (ORR) and complete response rate (CR) of venetoclax in combination with obinutuzumab and ibrutinib in patients with relapsed/refractory or previously untreated patients with CLL.
II. To estimate progression free survival (PFS) after treatment with venetoclax in combination with obinutuzumab and ibrutinib in patients with relapsed/refractory or previously untreated patients with CLL.
III. To conduct pharmacokinetic and pharmacodynamic studies of venetoclax in combination with obinutuzumab and ibrutinib in patients with relapsed/refractory or previously untreated patients with CLL.
IV. To examine pre-treatment and serial biomarkers associated with response and mechanisms of resistance to venetoclax, obinutuzumab and ibrutinib when given in combination for relapsed/refractory or previously untreated patients with CLL.
OUTLINE: This is a phase Ib, dose-escalation study of Bcl-2 inhibitor GDC-0199 followed by a phase II study.
Patients receive obinutuzumab intravenously (IV) on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 and 8 weeks, every 3 months for 2 years, and then every 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (obinutuzumab, ibrutinib, Bcl-2 inhibitor GDC-0199) | Experimental | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bcl-2 Inhibitor GDC-0199 | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib (Phase Ib) | 28 days (course 3) | |
| Minimal Residual Disease (MRD)-Complete Response (CR) Defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria (Phase II) | Assessments of MRD will be used in patients classified as CR to further evaluate their status as disease-free and if this further impacts their ability to remain progression-free and alive. MRD will be determined by high sensitivity 4 color flow cytometric analysis of the bone marrow using validated panels. | Up to 8 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | For all patients who receive at least one day of treatment, toxicities will be tabulated by type and grade and displayed in summary form. Serious adverse events are listed with "(SAE)" after the event name. | Up to 4 years |
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Inclusion Criteria:
Diagnosis of CLL meeting criteria established in the World Health Organization (WHO) classification of hematologic disorders
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Relapsed or refractory CLL patients must meet the following requirements:
Treatment-naïve CLL patients must meet the following requirements (Phase II only):
Hemoglobin >= 8 g/dL
Absolute neutrophil count (ANC) >= 1000/mm^3
Platelets >= 40,000/mm^3
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x ULN (excepting Gilbert's syndrome)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 × ULN
Serum creatinine < 2.0 mg/dL or creatinine clearance (Cockcroft) >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Female patients must be surgically sterile, post-menopausal (for at least 1 year), or have negative results from a pregnancy test performed as follows:
All female patients not surgically sterile or post-menopausal (for at least 1 year) and non-vasectomized male patients must practice at least one of the following methods of birth control:
Non-vasectomized male patients must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients who have had chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 28 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier; steroids for control of disease related symptoms are permitted
Patients who are receiving any other investigational agents
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
Active Richter's transformation
Known active involvement of the central nervous system by lymphoma or leukemia
Patients who require warfarin anticoagulation or who have received warfarin or equivalent vitamin K antagonists =< 7 days prior to treatment day 1; patients may be eligible if able to be taken off warfarin and started on an alternative anticoagulant
Received potent cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment
Received potent CYP3A4 inducers (such as rifampin, carbamazepine, phenytoin, St. John's wort) within 7 days prior to the first dose of study treatment
Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study treatment
History of a prior significant toxicity, other than thrombocytopenia, from another Bcl-2 family protein inhibitor
Known cysteine-481 Bruton's tyrosine kinase (BTK) mutation or CLL refractory to or progressed during ibrutinib or other Cys-481 binding BTK inhibitor treatment
Known infection with the human immunodeficiency virus (HIV) virus
A cardiovascular disability status of New York Heart Association class >= 2, defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain
Positive hepatitis serology:
Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis (e.g., patients with negative viral load after HCV-specific treatment)
History of severe (defined as grade 4 and/or requiring permanent discontinuation of prior antibody therapy) allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
Patients who received a live viral vaccination within 6 months prior to the first dose of study drug
A female patient who is pregnant or breast-feeding
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of other active malignancies other than CLL within the past 3 years prior to study entry, with the exception of:
Vaccination with a live vaccine < 28 days prior to the start of treatment
Inability to swallow capsules or tablets, or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Rogers, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34608724 | Derived | Arrato NA, Valentine TR, Byrd JC, Jones JA, Maddocks KJ, Woyach JA, Andersen BL. Illness representations and psychological outcomes in chronic lymphocytic leukaemia. Br J Health Psychol. 2022 May;27(2):553-570. doi: 10.1111/bjhp.12562. Epub 2021 Oct 4. | |
| 32795224 | Derived | Rogers KA, Huang Y, Ruppert AS, Abruzzo LV, Andersen BL, Awan FT, Bhat SA, Dean A, Lucas M, Banks C, Grantier C, Heerema NA, Lozanski G, Maddocks KJ, Valentine TR, Weiss DM, Jones JA, Woyach JA, Byrd JC. Phase II Study of Combination Obinutuzumab, Ibrutinib, and Venetoclax in Treatment-Naive and Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Nov 1;38(31):3626-3637. doi: 10.1200/JCO.20.00491. Epub 2020 Aug 14. |
| Label | URL |
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| The Jamesline | View source |
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Patients in the phase 1b dose escalation cohorts were enrolled and sequentially assigned to the appropriate dosing cohort. Enrollment was staggered to allow patients to start the ramp up period of venetoclax for the next cohort prior to the completion of the dose-limiting toxicity (DLT) observation period for the previous cohort. However, no patients escalated to a higher target dose until all patients had completed the DLT observation period from the previous cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b Cohort 100mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2024 |
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| Obinutuzumab | Biological | Given IV |
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| Ibrutinib | Drug | Given PO |
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| Pharmacological Study | Other | Correlative studies |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Number of Courses Started/Completed | May be summarized. | Up to 14 months |
| Number of Patients Who Reach the Target Dose of Bcl-2 Inhibitor GDC-0199 | May be summarized. | Up to 14 months |
| Number of Patients Requiring Dose Reductions | May be summarized. | Up to 14 months |
| Reason for Going Off Treatment | May be summarized. | Up to 14 months |
| Overall Response Rate | Overall response rate will be reported for all evaluable patients in the phase II setting, within and potentially across cohorts, assuming a binomial distribution. | Up to 4 years |
| Progression-free Survival (PFS) | Will be summarized by the Kaplan-Meier method for each of the phase II cohorts. | Time from first treatment date until the date of progression or death, whichever occurs first, assessed up to 8 years |
| Emotional Distress Assessment | Validated instruments will be administered serially to assess longitudinal changes in measures of health related quality of life using 36-Item Short Form Survey (SF-36) Mental Component Scale (MCS) T-scores for each time point with pairwise comparison p-values. Scores on the SF-36 scale range from 0 to 100, with higher scores indicating better mental health. Scores for the MCS are standardized using U.S. general population norms with summary scores set relative to a t-score mean of 50 and a standard deviation of 10. | Cycle 1 day 1, cycle 2 day 1, cycle 3 day 1, cycle 6 day 1 and cycle 12 day 1 |
| Health Related Quality of Life | Validated instruments will be administered serially to assess longitudinal changes in measures of health related quality of life using 36-Item Short Form Survey (SF-36) Physical Component Scale (PCS) T-scores for each time point with pairwise comparison p-values. Scores on the SF-36 scale range from 0 to 100, with higher scores indicating better physical health. Scores for the PCS are standardized using U.S. general population norms with summary scores set relative to a t-score mean of 50 and a standard deviation of 10. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1, and Cycle 12 Day 1 (each cycle is 28 days) |
| Serial Assessment of Immune Effector Cell Number and Function. | Peripheral blood immunophenotyping will be used to enumerate immune effector cells (counts and percentages of T-, and Natural Killer (NK)-cell subsets). | 4 weeks post-treatment |
| Baseline Prognostic Factors: Number of Prior Therapies | Relationships between baseline prognostic factors and response may be screened and analyzed quantitatively using logistic regression and adjusting for disease cohort, particularly if a sufficient number of patients respond to this combination therapy. | Baseline |
| Baseline Prognostic Factors: Tumor Lysis Syndrome (TLS) Risk | Relationships between baseline prognostic factors and response may be screened and analyzed quantitatively using logistic regression and adjusting for disease cohort, particularly if a sufficient number of patients respond to this combination therapy. | Baseline |
| Baseline Prognostic Factors: Hemoglobin | Baseline |
| Baseline Prognostic Factors: Investigations | Absolute neutrophil count (ANC), Absolute lymphocyte count (ALC) and Platelets. | Baseline |
| Baseline Prognostic Factor: Beta-2-microglobulin (B2M) | Beta-2-microglobulin (B2M) | At baseline |
| Baseline Prognostic Factors: Lactate Dehydrogenase (LDH) | lactate dehydrogenase (LDH) | At baseline |
| Baseline Prognostic Factors: Genetic Factors | At baseline |
| 30111609 | Derived | Rogers KA, Huang Y, Ruppert AS, Awan FT, Heerema NA, Hoffman C, Lozanski G, Maddocks KJ, Moran ME, Reid MA, Lucas M, Woyach JA, Whitlow WT, Jones JA, Byrd JC. Phase 1b study of obinutuzumab, ibrutinib, and venetoclax in relapsed and refractory chronic lymphocytic leukemia. Blood. 2018 Oct 11;132(15):1568-1572. doi: 10.1182/blood-2018-05-853564. Epub 2018 Aug 15. |
| FG001 | Phase 1b Cohort 200mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| FG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| FG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| FG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| FG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b Cohort 100mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG001 | Phase 1b Cohort 200mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Maximum Tolerated Dose of Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib (Phase Ib) | Maximum tolerated dose was only analyzed for phase l | Posted | Number | milligrams | 28 days (course 3) |
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| Primary | Minimal Residual Disease (MRD)-Complete Response (CR) Defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria (Phase II) | Assessments of MRD will be used in patients classified as CR to further evaluate their status as disease-free and if this further impacts their ability to remain progression-free and alive. MRD will be determined by high sensitivity 4 color flow cytometric analysis of the bone marrow using validated panels. | MRD was only measured for phase 2 of the study | Posted | Number | percentage of participants | Up to 8 weeks post-treatment |
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| Secondary | Number of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | For all patients who receive at least one day of treatment, toxicities will be tabulated by type and grade and displayed in summary form. Serious adverse events are listed with "(SAE)" after the event name. | Posted | Number | Number of Events | Up to 4 years |
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| Secondary | Number of Courses Started/Completed | May be summarized. | Posted | Number | number of subjects | Up to 14 months |
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| Secondary | Number of Patients Who Reach the Target Dose of Bcl-2 Inhibitor GDC-0199 | May be summarized. | Target dose of Bcl-2 inhibitor GDC-0199 only measured for Phase ll subjects | Posted | Count of Participants | Participants | Up to 14 months |
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| Secondary | Number of Patients Requiring Dose Reductions | May be summarized. | Posted | Count of Participants | Participants | Up to 14 months |
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| Secondary | Reason for Going Off Treatment | May be summarized. | Posted | Number | participants | Up to 14 months |
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| Secondary | Overall Response Rate | Overall response rate will be reported for all evaluable patients in the phase II setting, within and potentially across cohorts, assuming a binomial distribution. | Posted | Number | percentage of participants | Up to 4 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Will be summarized by the Kaplan-Meier method for each of the phase II cohorts. | Posted | Median | 95% Confidence Interval | months | Time from first treatment date until the date of progression or death, whichever occurs first, assessed up to 8 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Emotional Distress Assessment | Validated instruments will be administered serially to assess longitudinal changes in measures of health related quality of life using 36-Item Short Form Survey (SF-36) Mental Component Scale (MCS) T-scores for each time point with pairwise comparison p-values. Scores on the SF-36 scale range from 0 to 100, with higher scores indicating better mental health. Scores for the MCS are standardized using U.S. general population norms with summary scores set relative to a t-score mean of 50 and a standard deviation of 10. | In the phase 1b study, as not all patients were treated at the target dose of venetoclax, psychologic outcomes were not planned to be collected. In the newest cohort (the TN2 cohort) these studies were similarly not planned or included as adequate information had been gained on the outcomes measures from the original phase 2 cohorts. The number of analyzed participants at each time point represents the number of participants who completed the survey at that time point. | Posted | Mean | Standard Deviation | T-score | Cycle 1 day 1, cycle 2 day 1, cycle 3 day 1, cycle 6 day 1 and cycle 12 day 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life | Validated instruments will be administered serially to assess longitudinal changes in measures of health related quality of life using 36-Item Short Form Survey (SF-36) Physical Component Scale (PCS) T-scores for each time point with pairwise comparison p-values. Scores on the SF-36 scale range from 0 to 100, with higher scores indicating better physical health. Scores for the PCS are standardized using U.S. general population norms with summary scores set relative to a t-score mean of 50 and a standard deviation of 10. | In the phase 1b study, as not all patients were treated at the target dose of venetoclax, psychologic outcomes were not planned to be collected. In the newest cohort (the TN2 cohort) these studies were similarly not planned or included as adequate information had been gained on the outcomes measures from the original phase 2 cohorts. The number of analyzed participants at each time point represents the number of participants who completed the survey at that time point. | Posted | Mean | Standard Deviation | T-score | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1, and Cycle 12 Day 1 (each cycle is 28 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Serial Assessment of Immune Effector Cell Number and Function. | Peripheral blood immunophenotyping will be used to enumerate immune effector cells (counts and percentages of T-, and Natural Killer (NK)-cell subsets). | In the phase 1b study, as not all patients were treated at the target dose of venetoclax, immune cell subsets were not planned to be collected. In the TN2 cohort these studies were similarly not planned or included as adequate information had been gained on the outcomes measures from the original phase 2 cohorts. Five participants from the Phase 2 RR cohort and four participants from the TN1 cohort did not complete treatment or were unable to have data collected for immune cell subsets. | Posted | Mean | Standard Deviation | 10^3 cells/uL | 4 weeks post-treatment |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factors: Number of Prior Therapies | Relationships between baseline prognostic factors and response may be screened and analyzed quantitatively using logistic regression and adjusting for disease cohort, particularly if a sufficient number of patients respond to this combination therapy. | Posted | Median | Full Range | Number of Prior Therapies | Baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factors: Tumor Lysis Syndrome (TLS) Risk | Relationships between baseline prognostic factors and response may be screened and analyzed quantitatively using logistic regression and adjusting for disease cohort, particularly if a sufficient number of patients respond to this combination therapy. | Posted | Number | participants | Baseline |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factors: Hemoglobin | One participant in the TN2 cohort did not have hemoglobin measured at baseline. | Posted | Median | Full Range | grams per deciliter | Baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factors: Investigations | Absolute neutrophil count (ANC), Absolute lymphocyte count (ALC) and Platelets. | Posted | Median | Full Range | 10^3 cells/uL | Baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factor: Beta-2-microglobulin (B2M) | Beta-2-microglobulin (B2M) | Posted | Median | Full Range | milligrams per liter | At baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factors: Lactate Dehydrogenase (LDH) | lactate dehydrogenase (LDH) | Posted | Median | Full Range | units per liter | At baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Prognostic Factors: Genetic Factors | The number of participants analyzed for each genetic factor represents the number of participants for which data was available for that genetic factor. The number of participants with High Hyperdiploid (HeH), was not a prespecified baseline measure so data was not collected for the phase 1b cohorts. | Posted | Number | participants | At baseline |
|
Up to 4 years
All treatment arms were combined for adverse event reporting, since all arms received the same treatment regimen.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b Cohort 100mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2 and 100mg in week 3. The 100mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | 1 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Phase 1b Cohort 200mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | 0 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | 0 | 6 | 2 | 6 | 6 | 6 |
| EG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | 1 | 25 | 12 | 25 | 25 | 25 |
| EG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | 1 | 25 | 7 | 25 | 25 | 25 |
| EG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | 1 | 25 | 11 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Stroke | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Alanine Aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Blurred Vision | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Bronchial Infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Bullous Dermatitis | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Non-cardiac Chest Pain | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chest pain - Cardiac | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| High Cholesterol | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dry Eyes | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flu like Symptoms | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hearing Impaired | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hot Flashes | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lymph Node Pain | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Lymphocyte Count Increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nail Loss | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus Disorder | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus Pain | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Testicular Pain | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Weight Gain | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Eye disorders - Other | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gum infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v.5.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Vascular disorders - Other | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Edema cerebral | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Flashing lights | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hypersomnia | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Periorbital edema | General disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
| |
| Paronychia | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kerry Rogers | The Ohio State University Comprehensive Cancer Center | 614-293-3873 | Kerry.Rogers@osumc.edu |
| Mar 12, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2024 | Mar 12, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| C543332 | obinutuzumab |
| C551803 | ibrutinib |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
|
|
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG001 | Phase 1b Cohort 200mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The 200mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG001 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG002 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Bcl-2 Inhibitor GDC-0199: Given PO
Obinutuzumab: Given IV
Ibrutinib: Given PO
Pharmacological Study: Correlative studies
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
| OG002 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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| OG002 | Phase 1b Cohort 400mg Venetoclax (GDC-0199) | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. GDC-0199 is administered through a dose ramp-up throughout course 3 with 20 mg administered in week 1, 50mg in week 2, 100mg in week 3 and 200mg in week 4. The dose of GDC-0199 increases to 400mg starting week 1 of course 4. The 400mg dose level continues through the rest of the treatment period. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG003 | Phase 2 Relapsed/Refractory | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG004 | TN1: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| OG005 | TN2: Phase 2 Treatment Naïve | Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity. Bcl-2 Inhibitor GDC-0199: Given PO Obinutuzumab: Given IV Ibrutinib: Given PO Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
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