Ibrutinib + Fludarabine for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byInhye Ahn, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a pilot phase 2 study investigating the safety and efficacy of ibrutinib combined with short-course fludarabine in previously untreated CLL patients. Ibrutinib will be given daily until disease progression or intolerable side effects occur. Fludarabine will be given in cycles 3 and 4. The primary efficacy endpoint is the rate of complete response after 6 cycles or 24 weeks. The primary safety endpoint is the rate of treatment discontinuation after 6 cycles or 24 weeks.

Eligibility Criteria

This trial is for adults with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who have certain blood cell counts and are able to perform daily activities. They must not have had previous CLL treatments, be free from significant heart disease, active infections like Hepatitis B/C or HIV, and agree to use effective contraception.

Inclusion Criteria

I have CLL/SLL and have not received any treatment yet.

I can perform daily activities with minimal assistance.

Agreement to use acceptable methods of contraception, negative pregnancy test for females of childbearing potential, and willingness to participate in all study procedures

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Exclusion Criteria

Psychiatric illness/social situations limiting patient's ability to comply with study requirements, inability to understand the study or give informed consent

I do not have severe liver, kidney, or other life-threatening health issues.

Major surgery within specific timeframe, currently active, clinically significant cardiovascular disease, subjects who received or require strong CYP3A inhibitors

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Treatment Details

Interventions

Fludarabine (Anti-metabolites)
Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial OverviewThe study tests the combination of Ibrutinib taken daily until disease progression or side effects become intolerable, with Fludarabine given in short courses. The main goals are to see how many patients achieve a complete response after 6 cycles and monitor those who stop treatment due to side effects within the same period.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Ibrutinib and short-course fludarabineExperimental Treatment2 Interventions

* Ibrutinib 420 mg PO daily for the duration of the study * Fludarabine 25 mg/m2/day IV on days 1-5 of cycles 3 and 4

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

🇪🇺 Approved in European Union as Fludara for: