Venetoclax + Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Michael Choi, MD - Hematology - Blood ...

Overseen byMichael Choi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Michael Choi

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with CLL or SLL that's not improving on Ibrutinib alone. Participants must have been on Ibrutinib, be able to become pregnant and agree not to during the study, and have good blood, liver, and kidney function. Exclusions include significant heart disease history, active hepatitis B/C, severe liver impairment, CNS leukemia/lymphoma, certain prior cancers or surgeries.

Inclusion Criteria

I have been diagnosed with B cell CLL or SLL and my disease can be measured.

I agree not to become pregnant during the study.

My blood, liver, and kidney functions are all within normal ranges.

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Exclusion Criteria

I have been diagnosed with CNS lymphoma or leukemia.

I have an active hepatitis B or C infection.

I have not had a heart attack or significant heart disease in the last 6 months.

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Treatment Details

Interventions

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Venetoclax (BCL-2 Inhibitor)

Trial OverviewThe study tests a combination of Venetoclax with high-dose Ibrutinib (up to 840 mg daily) in patients whose CLL/SLL isn't responding to just Ibrutinib. The goal is to see if this combo can better reduce cancer cells. Both drugs are FDA-approved separately but used together at these doses is experimental.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: venetoclax with high-dose ibrutinibExperimental Treatment2 Interventions

venetoclax with high-dose ibrutinib for the treatment of patients with chronic lymphocytic leukemia with progressive disease on single agent ibrutinib.

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

🇪🇺 Approved in European Union as Imbruvica for: