A Phase 1 interventional study of Venetoclax and Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Michael Choi. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Michael Choi · Phase 1, Interventional, and Treatment
The purpose of the study is to investigate whether the combination of venetoclax and ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL that is not responding or no longer responding to treatment with ibrutinib alone. The study will evaluate whether this regimen can reduce the amount of cancerous cells in your body. If you agree, you will receive ibrutinib at a dose of up to 840 mg a day by mouth, as well as venetoclax. Although both of these agents are approved by the FDA for the treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are considered experimental.
This is phase 1 study for patients with CLL or small lymphocytic lymphoma (SLL) experiencing disease progression on single ibrutinib. This study will evaluate the optimal ibrutinib dose (including doses higher than 420 mg) when combined with venetoclax
During the screening period, patients will continue on ibrutinib at their previous tolerated dose, unless required to stop (e.g.: by a preceding clinical trial).
On cycle 1, day 1, the dose of ibrutinib will be assigned based on the dose cohort. Patients in cohort 1 will receive ibrutinib 420 mg PO daily. Patients in cohort 2 will receive ibrutinib 560 mg PO daily. Cohort 3 will be 840 mg PO daily.
On cycle 1, day 1, patients will initiate venetoclax. The dose of venetoclax will ramp-up from 20 mg PO daily to 400 mg PO daily over a 5 week period.
The primary safety endpoint is determination of DLTs during the first 35 days (completion of dose ramp up). The primary efficacy endpoint of overall response rate will be assessed on approximately Cycle 7, Day 1.
Rationale: The optimal management of patients that progress on ibrutinib, including those with acquired Btk or PLCg2 mutations, is not determined. In other cancers, continued treatment with small molecule inhibitors beyond disease progression provides significant benefit, with additional agents or adjustments to ablate the resistant subclone. Venetoclax is approved for the treatment of patients with CLL, and is well-tolerated and effective in high-risk disease, and so is an appropriate agent for this trial.
1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Michael Choi is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
venetoclax with high-dose ibrutinib for the treatment of patients with chronic lymphocytic leukemia with progressive disease on single agent ibrutinib.
Drug: Venetoclax · Drug: Ibrutinib
On cycle 1, day 1, patients will initiate venetoclax. The dose of venetoclax will ramp-up from 20 mg PO daily to 400 mg PO daily over a 5 week period.
Also known as: Venclexta
During the screening period, patients will continue on ibrutinib at their previous tolerated dose, unless required to stop (e.g.: by a preceding clinical trial). On cycle 1, day 1, the dose of ibrutinib will be assigned based on the dose cohort. Patients in cohort 1 will receive ibrutinib 420 mg PO daily. Patients in cohort 2 will receive ibrutinib 560 mg PO daily. Cohort 3 will be 840 mg PO daily.
Also known as: Imbruvica
Maximum tolerated dose or biologically active dose.
Maximum tolerated dose or biologically active dose.
Time frame: 1 year or more
Treatment-emergent adverse events
Treatment-emergent adverse events (description, timing, grade \[CTCAE v4.03\], severity, seriousness, and relatedness)
Time frame: 2 years or more
Overall response rate
Partial Response, Partial Response with Lymphocytosis, and Complete Response) based on international working group guidelines. Best overall response will be determined
Time frame: 2 years or more
Progression free survival rate at completion of combination therapy
Progression free survival rate at completion of combination therapy, duration of response, as determined by International Working Group in CLL (iwCLL) criteria.
Time frame: 2 years or more
Stable disease rate
Stable disease rate (also based on 2008 iwCLL guidelines), also at the time of primary endpoint response assessment.
Time frame: 2 years or more
Started May 2018 (actual). Primary completion is estimated for Aug 2024, 75 months after the start.
Of 89 non-industry phase 1 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 90. This study's planned 75 months is above that.
Counting every sponsor, half of 177 studies reached it within 55 months; a quarter within 38 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Venetoclax · Ibrutinib
Leukemia, Lymphocytic, Chronic, B-Cell →
Michael Choi