Ibrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byMatthew S. Davids

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

Eligibility Criteria

Adults diagnosed with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma who need treatment and have previously had therapy that didn't work. They must not be pregnant, agree to use contraception, and should not have severe allergies to monoclonal antibodies or a history of certain other cancers. Major organ functions must meet specific criteria, and they can't join if they've recently had surgery, infections requiring systemic treatment, heart issues, or are on strong CYP3A inhibitors.

Inclusion Criteria

- Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of <6 months.

I can do most of my daily activities without help.

My blood test results meet the study's requirements, unless my bone marrow biopsy shows significant leukemia involvement.

+17 more

Exclusion Criteria

I have had cancer before, but it was a different type.

My prostate cancer is low-risk and I am being actively monitored.

I haven't taken strong immune system suppressants or more than 20 mg/day of prednisone in the last 28 days.

+19 more

Participant Groups

The trial is testing the effectiveness of combining two drugs: Ibrutinib and Obinutuzumab in treating Chronic Lymphocytic Leukemia (CLL). Participants will receive both medications as part of their treatment regimen to see how well they work together against CLL.

3Treatment groups

Experimental Treatment

Group I: Arm C- obinutuzumab/ibrutinibExperimental Treatment2 Interventions

Participants enrolled in Arm C will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. At the same time, participants will begin to receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6.

Group II: Arm B- ibrutinib -> obinutuzumabExperimental Treatment2 Interventions

Participants enrolled in Arm B will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. Participants will begin to receive obinutuzumab weekly starting cycle 2, and will receive obinutuzumab monthly during cycles 3-7

Group III: Arm A- obinutuzumab -> ibrutinibExperimental Treatment2 Interventions

Participants enrolled in Arm A will receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6. Participants will begin to take ibrutinib daily starting cycle 2 and will continue with daily ibrutinib until the end of treatment.

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

🇪🇺 Approved in European Union as Imbruvica for: