Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byKerry Rogers, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well venetoclax and ibrutinib work in treating participants with chronic lymphocytic leukemia and have developed genetic mutations after previously being treated with ibrutinib. Venetoclax and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for people with chronic lymphocytic leukemia who have developed resistance to a drug called Ibrutinib. Participants must have certain blood cell counts, be able to perform daily activities with minimal assistance (ECOG ≤ 2), and show specific genetic mutations linked to the resistance. They should not have uncontrolled autoimmune reactions affecting their blood cells.

Inclusion Criteria

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ≤ ULN

Ability to understand and sign a written informed consent

My bone marrow works well on its own, or any issues are due to my CLL.

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Exclusion Criteria

I may have had hepatitis but my current tests show no active virus.

I cannot continue taking ibrutinib for any reason.

I have uncontrolled autoimmune blood disorders.

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Treatment Details

Interventions

Ibrutinib (Tyrosine Kinase Inhibitor)
Venetoclax (BCL-2 Inhibitor)

Trial OverviewThe study is testing the combination of two drugs, Venetoclax and Ibrutinib, in patients whose leukemia has stopped responding to Ibrutinib alone. The goal is to see if this combo can block cancer growth by shutting down enzymes that cancer cells need.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax, ibrutinib)Experimental Treatment3 Interventions

Participants receive venetoclax PO daily on days 1-28 and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 12 or 24 courses in the absence of disease progression or unacceptable toxicity. Participants with MRD negativity after 12 or 24 courses discontinue treatment, while participants with MRD positivity continue treatment with venetoclax in the absence of disease progression or unacceptable toxicity.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: