Ibrutinib + Venetoclax for Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Georgetown University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.

Eligibility Criteria

Adults with grade 1-3a follicular lymphoma that's come back or hasn't responded to at least two prior treatments. They should have symptoms, low blood counts, large tumors, or other specific conditions listed in the criteria. Participants need normal organ function and can't be on certain medications or have had recent major surgery.

Inclusion Criteria

All risk by FLIPI 0-5 factors (Appendix I)

I have undergone at least two different treatments for my condition.

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

Exclusion Criteria

Lactating or pregnant.

I do not have any ongoing infections that aren’t being treated.

I had cancer before, but it was treated, and I've been cancer-free for over 3 years.

Participant Groups

The trial is testing Ibrutinib and Venetoclax in people with relapsed/refractory follicular lymphoma. It starts by finding the highest dose patients can take without serious side effects (phase I) and then checks how well it works at that dose (phase II).

Group I: Phase II Dose Experimental Treatment 2 Interventions

The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion.

Group II: Phase I - Dose Level 3 Experimental Treatment 2 Interventions

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg Each medication is taken daily. Treatment cycles are 28 days long.

Group III: Phase I - Dose Level 2 Experimental Treatment 2 Interventions

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg Each medication is taken daily. Treatment cycles are 28 days long.

Group IV: Phase I - Dose Level 1 Experimental Treatment 2 Interventions

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long.

Group V: Phase I - Dose Level 0 Experimental Treatment 2 Interventions

Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long.

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

🇪🇺 Approved in European Union as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

🇺🇸 Approved in United States as Imbruvica for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

🇨🇦 Approved in Canada as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma

🇯🇵 Approved in Japan as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Georgetown Lombardi Comprehensive Cancer Center Washington, United States

Seattle Cancer Care Alliance Seattle, WA

John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ

Who Is Running the Clinical Trial?

Georgetown University Lead Sponsor

AbbVie Industry Sponsor

Pharmacyclics LLC. Industry Sponsor

Hackensack Meridian Health Collaborator

References