Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen ByKami Maddocks, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kami Maddocks, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This is a Phase II, single institution open-label, non-randomized monotherapy study to evaluate the clinical efficacy and durable disease control of PCI-32765 administered to patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having deletion 17p13 independently evaluated.

Eligibility Criteria

This trial is for adults with relapsed or refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia who have failed at least one prior therapy. They should be in relatively stable condition (ECOG <=2), have a life expectancy over 2 months, and normal organ function as defined by specific blood test levels.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My CLL/SLL has come back or didn't respond to treatment, and I've tried at least one therapy.

I agree to use birth control during and for 30 days after the study if I can have children.

+7 more

Participant Groups

The study tests the effectiveness of Ibrutinib (PCI-32765) on its own in patients with certain types of leukemia and lymphoma that haven't responded to previous treatments. It's an open-label Phase II trial where everyone gets the drug; there's no comparison group.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib)Experimental Treatment3 Interventions

Patients will be treated with PCI-32765 capsules administered orally once daily at a dose of 420 mg for 28 day cycles. Weekly monitoring during the first month will occur followed by monthly evaluations for 2 additional months. Monitoring for patients at this point would be every 3 months with monthly CBC(complete blood count)and phone follow-up with a co-investigator on the study. A standard questionnaire will be used in this monthly phone assessment. Patients will continue to receive the study drug indefinitely as long as they are deriving clinical benefit (Complete Response or Partial Response or Stable Disease) and not experiencing any unacceptable toxicity. Subjects with disease progression will be removed from the study. Correlative laboratory samples, quality of life assessment, and immunologic data would be collected over time of therapy.

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

🇪🇺 Approved in European Union as Imbruvica for: