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| ID | Type | Description | Link |
|---|---|---|---|
| TGR-IB-105 | Other Identifier | TG Therapeutics |
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| Name | Class |
|---|---|
| TG Therapeutics, Inc. | INDUSTRY |
| The Leukemia and Lymphoma Society | OTHER |
| Blood Cancer Research Partnership | OTHER |
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This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.
This research study is a Phase I and Ib combination clinical trial, which aims to both evaluate the safety of an investigational drug combination and also tries to define the appropriate dose of the investigational drug to evaluate in later clinical trials. "Investigational" means that the intervention is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved TGR-1202 in the United States for use in MCL/CLL/SLL cancers.
TGR-1202 is a newly developed drug that may stop cancer cells from growing based on recent laboratory experiments. The results from these experiments suggest this drug may help to kill cancer cells when coupled with ibrutinib. In this research study, the safety and tolerability of TGR-1202 is being investigated to determine the highest dose that can safely be used in combination with ibrutinib. The study is also aimed to evaluate whether TGR-1202 has any effect on tumor growth (nodal response), and to determine the overall repsonse rate and duration of response in patients with CLL/SLL or MCL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLL | Experimental | Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
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| MCL | Experimental | Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGR-1202 | Drug | Capsules taken whole daily with water and with food |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I | To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting >7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting > 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade >2 hemorrhage;Grade ≥ 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade ≥3 lab abnormalities that resolve to ≤ Grade 1 or baseline within 7 days;treatment delay of ≥14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting. | Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) by Lugano Criteria ( Cheson et al,.24) for MCL. | At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter |
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Inclusion Criteria:
Exclusion Criteria:-
Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 3 weeks of Cycle 1/Day 1,
Autologous hematologic stem cell transplant within 3 months of study entry.
Allogeneic hematologic stem cell transplant within 12 months.
Evidence of active Hepatitis B,Hepatitis C or HIV infection.
Active central nervous system involvement by lymphoma
Requires treatment with strong CYP3A4/5 inhibitors
Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
QTcF >470 msec (QT interval, Fredericia calculation)
Angina not well-controlled by medication
Poorly controlled or clinically significant atherosclerotic vascular disease
Presence of other active cancers, or history of treatment for invasive cancer within the past 2 years.
Require warfarin for anticoagulation
Women who are pregnant or lactating
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Davids, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Care | Monterey | California | 93940 | United States | ||
| St. Francis Hospital and Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30558987 | Derived | Davids MS, Kim HT, Nicotra A, Savell A, Francoeur K, Hellman JM, Bazemore J, Miskin HP, Sportelli P, Stampleman L, Maegawa R, Rueter J, Boruchov AM, Arnason JE, Jacobson CA, Jacobsen ED, Fisher DC, Brown JR; Blood Cancer Research Partnership of the Leukemia and Lymphoma Society. Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicentre phase 1-1b study. Lancet Haematol. 2019 Jan;6(1):e38-e47. doi: 10.1016/S2352-3026(18)30196-0. Epub 2018 Dec 14. |
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Participants in the Phase I portion of the study enrolled in outpatient clinic setting from 11/20/2014 to 12/22/2018 and to the Phase II study from 1/14/2016 to 5/29/2018. The MCL and CLL arms were enrolled independently of each other, and were allowed to begin enrolling to the protocol scheduled expansion independent of the other arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLL: Phase I Cohort 1 | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| 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 | Oct 23, 2019 |
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| Ibrutinib | Drug | Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges |
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| Rate of Nodal Partial Response With Lymphocytosis (nPR) | nPR will only be evaluated in CLL patients, defined as percentage of patients achieved nodal PR. As per Cheson et al., 2012, patients who achieve a radiographic PR but continue to have a lymphocytosis with >5,000 B-lymphocytes per μL are considered to have a nodular partial response, also known as PR with lymphocytosis, due to the fact that they appear to derive a similar clinical benefit from BCR inhibitors as patients who achieve a traditional PR. | At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter |
| Median Progression-Free Survival (PFS) | Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment. | Disease will be evaluated at baseline, cycle 1 day 1,8,15,22 and cycle 2 day 1,15, and cycle 3-6 on day1, and every 2 cycles until cycle 12, then every 3 cycles thereafter. In long-term follow-up, survival will be followed every 3 cycles up to 2 years. |
| Median Duration of Overall Response (DOR) | Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per 2008 IWCLL Criteria, until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment. | Disease response will be evaluated at baseline, cycle 1 day 1,8,15,22 and cycle 2 day 1,15, and cycle 3-6 on day1, and every 2 cycles until cycle 12, then every 3 cycles thereafter. |
| Hartford |
| Connecticut |
| 06105 |
| United States |
| Eastern Maine Medical Center/ Northern Light Cancer Care | Brewer | Maine | 04412 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | United States |
| FG001 |
| MCL: Phase I Cohort 1 |
Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| FG002 | CLL: Phase I Cohort 2 | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| FG003 | MCL: Phase I Cohort 2 | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| FG004 | CLL: Phase I/II Cohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| FG005 | MCL: Phase I/II Cohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
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| ID | Title | Description |
|---|---|---|
| BG000 | CLL: Phase I Cohort 1 | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| BG001 | MCL: Phase 1 Cohort 1 | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| BG002 | CLL: Phase I Cohort 2 | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| BG003 | MCL: Phase I Cohort 2 | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| BG004 | CLL Phase I/IICohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| BG005 | MCL Phase I/II Cohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | 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 | Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I | To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting >7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting > 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade >2 hemorrhage;Grade ≥ 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade ≥3 lab abnormalities that resolve to ≤ Grade 1 or baseline within 7 days;treatment delay of ≥14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting. | Patients who have been previously treated for MCL, CLL or SLL. MCL must have 1 measurable site of disease and have had received at least one prior standard therapy; CLL/SLL patients must have an indication for treatment according to 2008 ICWLL criteria and received at least one prior standard treatment regimen | Posted | Count of Participants | Participants | Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I |
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| Secondary | Overall Response Rate (ORR) | The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) by Lugano Criteria ( Cheson et al,.24) for MCL. | all the patients were pooled together from ph1 and ph1b for the final efficacy analysis | Posted | Number | 95% Confidence Interval | percentage of participants | At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter |
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| Secondary | Rate of Nodal Partial Response With Lymphocytosis (nPR) | nPR will only be evaluated in CLL patients, defined as percentage of patients achieved nodal PR. As per Cheson et al., 2012, patients who achieve a radiographic PR but continue to have a lymphocytosis with >5,000 B-lymphocytes per μL are considered to have a nodular partial response, also known as PR with lymphocytosis, due to the fact that they appear to derive a similar clinical benefit from BCR inhibitors as patients who achieve a traditional PR. | all the patients were pooled together from ph1 and ph1b for the final efficacy analysis | Posted | Number | percentage of patients | At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter |
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| Secondary | Median Progression-Free Survival (PFS) | Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment. | all the patients were pooled together from ph1 and ph1b for the final efficacy analysis | Posted | Median | 95% Confidence Interval | months | Disease will be evaluated at baseline, cycle 1 day 1,8,15,22 and cycle 2 day 1,15, and cycle 3-6 on day1, and every 2 cycles until cycle 12, then every 3 cycles thereafter. In long-term follow-up, survival will be followed every 3 cycles up to 2 years. |
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| Secondary | Median Duration of Overall Response (DOR) | Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per 2008 IWCLL Criteria, until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment. | all the patients were pooled together from ph1 and ph1b for the final efficacy analysis | Posted | Median | 95% Confidence Interval | months | Disease response will be evaluated at baseline, cycle 1 day 1,8,15,22 and cycle 2 day 1,15, and cycle 3-6 on day1, and every 2 cycles until cycle 12, then every 3 cycles thereafter. |
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Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation.
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLL: Phase I Cohort 1 | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG001 | MCL: Phase I Cohort 1 | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG002 | CLL: Phase I Cohort 2 | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | MCL: Phase I Cohort 2 | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG004 | CLL: Phase I/IICohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | 2 | 15 | 3 | 15 | 15 | 15 |
| EG005 | MCL: Phase I/II Cohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | 3 | 15 | 5 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Sudden Death | General disorders | CTCAE (4.0) | Systematic Assessment | Suspected adrenal insufficiency and suspected disease progression- both without autopsy |
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| Paraspinal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Fungal Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Blurred vision | Eye disorders | CTCAE 4.0 | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | CTCAE 4.0 | Systematic Assessment |
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| Hematoma | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Lip pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Lipase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Localized edema | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Malaise | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Nail infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Skin/subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment | Various types of non specific rashes |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Davids, MD, MMSc | Dana-Farber Cancer Institute | 617-632-6331 | matthew_davids@dfci.harvard.edu |
| May 6, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-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 |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626319 | umbralisib |
| C551803 | ibrutinib |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG005 | MCL Phase I/II Cohort 3 (RPD2) | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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