Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byNitin Jain, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson 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 patients with chronic or small lymphocytic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may help control chronic or small lymphocytic leukemia.

Eligibility Criteria

This trial is for patients with chronic or small lymphocytic leukemia who are in good physical condition (ECOG <=2) and have properly functioning kidneys and liver. It includes those untreated with high-risk features, relapsed after prior therapy, or free from other malignancies for 2 years. Pregnant women, HIV-positive individuals, those with active infections or hepatitis B/C, recent recipients of certain therapies, and anyone on strong CYP3A inhibitors/inducers can't participate.

Inclusion Criteria

I have been diagnosed with CLL/SLL.

My condition did not improve after at least one treatment.

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN, unless clearly due to disease involvement

+8 more

Exclusion Criteria

I am HIV positive and understand there may be interactions with my medication.

I do not have an active hepatitis B infection, or I am vaccinated against it.

I do not have serious heart problems like uncontrolled heart rhythm issues or recent heart attacks.

+11 more

Participant Groups

The study tests the combination of venetoclax and ibrutinib to treat chronic/small lymphocytic leukemia. Venetoclax aims to block a protein that cancer cells need to survive while Ibrutinib targets enzymes important for cell growth. The goal is to see if this drug combo can control the disease better than current treatments.

1Treatment groups

Experimental Treatment

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

Patients receive ibrutinib PO QD on days 1-28. Beginning on day 1 of cycle 4, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients with residual disease or who are positive for MRD after cycle 27 may continue treatment with ibrutinib.

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

🇪🇺 Approved in European Union as Imbruvica for: