Combination Therapy for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+983 other locations

Overseen byTait D Shanafelt

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib, obinutuzumab, and venetoclax may work better than giving ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia.

Eligibility Criteria

Adults aged 18-70 with chronic lymphocytic leukemia who haven't had prior CLL treatments, have progressive symptoms or blood abnormalities, and meet specific health criteria. They must not be pregnant/breastfeeding, have certain heart conditions or infections, take strong CYP3A inhibitors/inducers, or have other active cancers.

Inclusion Criteria

Total bilirubin =< 1.5 x ULN

SGOT/SGPT =< 3.0 x ULN

I am not currently using corticosteroids, or only using low doses for non-blood related conditions.

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Exclusion Criteria

I have severe heart failure.

Positive serology for hepatitis B

On other investigational agents

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Treatment Details

Interventions

Ibrutinib (Kinase Inhibitor)
Obinutuzumab (Monoclonal Antibodies)
Venetoclax (BCL-2 Inhibitor)

Trial OverviewThe trial is testing if adding Venetoclax to Ibrutinib and Obinutuzumab treatment provides better outcomes for chronic lymphocytic leukemia patients than just Ibrutinib and Obinutuzumab. It includes biospecimen collection, CT scans, bone marrow biopsies, and quality-of-life assessments.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (ibrutinib, obinutuzumab, venetoclax)Experimental Treatment7 Interventions

Patients receive ibrutinib PO daily on days 1-28 and obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 1-28 of cycles 3-14. Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and CT scans before and after treatment and collection of blood throughout the study.

Group II: Arm B (ibrutinib, obinutuzumab)Active Control6 Interventions

Patients receive ibrutinib PO and obinutuzumab as in arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and CT scans before and after treatment and collection of blood throughout the study.

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

🇪🇺 Approved in European Union as Imbruvica for: