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Investigator decision to close study
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may be a better treatment for patients with Richter's Transformation. Depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also called vincristine, and P= prednisolone or prednisone (corticosteroids).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fit arm | Experimental | ibrutinib and obinutuzumab in combination with the CHOP regimen |
|
| Frail arm | Experimental | ibrutinib and obinutuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improved Hemoglobin and Platelet Counts. | hematologic improvement | 6 months |
| Progression Free Survival (PFS) | time to progression post treatment of condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Barrientos, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health/CLL Research and Treatment Program | New Hyde Park | New York | 11042 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fit Arm | ibrutinib and obinutuzumab in combination with the CHOP regimen Obinutuzumab: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 Ibrutinib: 560mg po daily CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone |
| FG001 | Frail Arm | ibrutinib and obinutuzumab Obinutuzumab: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 Ibrutinib: 560mg po daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants were only randomized to the Fit arm, no participants were in the Frail arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fit Arm | ibrutinib and obinutuzumab in combination with the CHOP regimen Obinutuzumab: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 Ibrutinib: 560mg po daily CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP) | No data was collected for this outcome measure. | Posted | 6 months |
|
1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
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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 | Fit Arm | ibrutinib and obinutuzumab in combination with the CHOP regimen Obinutuzumab: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 Ibrutinib: 560mg po daily CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment | Grade 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peripheral neuropathy | Nervous system disorders | Systematic Assessment | Grade 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Barrientos, MD | Northwell Health | 516-470-4050 | jbarrientos@northwell.edu |
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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 | Jun 21, 2018 | Nov 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| C551803 | ibrutinib |
| C036337 | VAP-cyclo protocol |
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parallel assignment based on fitness of participants
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|
| Ibrutinib | Drug | 560mg po daily |
|
|
| CHOP | Other | cyclophosphamide, doxorubicin, vincristine, and prednisone |
|
|
| 6 months |
| To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue) | health-related quality of life using FACIT Fatigue Scale | 1 year |
| Frail Arm |
ibrutinib and obinutuzumab Obinutuzumab: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 Ibrutinib: 560mg po daily |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Number of Participants With Improved Hemoglobin and Platelet Counts. | hematologic improvement | No data was collected for this outcome measure. | Posted | 6 months |
|
|
| Secondary | Progression Free Survival (PFS) | time to progression post treatment of condition | No participants were enrolled into the Frail Arm. No data was collected for the Frail Arm, there are no results to report. Data reported for the Fit Arm is estimated. | Posted | Median | Standard Deviation | Months | 6 months |
|
|
|
| Secondary | To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue) | health-related quality of life using FACIT Fatigue Scale | No data was collected for this outcome measure. | Posted | 1 year |
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Frail Arm | ibrutinib and obinutuzumab Obinutuzumab: 100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6 Ibrutinib: 560mg po daily | 0 | 0 | 0 | 0 | 0 | 0 |
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Grade 3 |
|
| constipation | Gastrointestinal disorders | Systematic Assessment | Grade 1 |
|
| hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment | Grade 1 |
|
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment | Grade 1 |
|
| fatigue | General disorders | Systematic Assessment | Grade 2 |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Alkaline phosphatase elevated | Investigations | Systematic Assessment |
|
| ALT increased | Investigations | Systematic Assessment |
|
| AST increased | Investigations | Systematic Assessment |
|
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