Lenalidomide + Ibrutinib for Lymphoma

Palo Alto (17 mi)

Overseen byBeth A Christian

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib in treating patients with B-cell non-Hodgkin lymphoma that has returned (relapsed) or not responded to treatment (refractory). Lenalidomide helps shrink or slow the growth of non-Hodgkin lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide with ibrutinib may work better in treating non-Hodgkin lymphoma than giving either drug alone.

Eligibility Criteria

This trial is for adults with certain types of B-cell non-Hodgkin lymphoma that have relapsed or are refractory. Participants must have had at least one prior therapy, be in fairly good health (ECOG <=2), and not pregnant or nursing. They should understand the study and consent to participate. Those with active infections, recent major surgery, known allergies to trial drugs, or on specific medications are excluded.

Inclusion Criteria

All possible curative treatments have been tried or are not suitable for me.

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

My lymphoma is a specific type of B-cell non-Hodgkin's.

I am 18 years old or older.

My organs and bone marrow work well without needing extra help.

Exclusion Criteria

I need medication to prevent blood clots.

I do not have any uncontrolled illnesses or social situations that could affect my participation.

My lymphoma has spread to my brain or spinal cord.

I am allergic to lenalidomide or similar drugs.

I am not on any immune-suppressing drugs except for corticosteroids.

I have been treated with a BTK inhibitor before.

I have no lasting side effects from previous cancer treatments.

I cannot swallow pills or have major digestive issues.

I have a bleeding disorder or hemophilia.

I am taking medication that strongly affects liver enzymes.

I am not taking any medications known to cause heart rhythm problems.

I have a serious liver condition.

I need to take 20 mg or more of corticosteroids daily.

Treatment Details

The trial is testing the combination of two drugs: Lenalidomide and Ibrutinib. It aims to find the safest dose while assessing how well these drugs work together against various subtypes of B-cell non-Hodgkin lymphoma compared to using them separately.

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, ibrutinib)Experimental Treatment8 Interventions

Patients receive lenalidomide PO on days 1-21 and ibrutinib PO on days 1-28 (days 2-28 of cycle 1). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT or PET/CT throughout the study. Patients may undergo bone marrow biopsy and aspiration and MRI as clinically indicated.

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

🇪🇺 Approved in European Union as Imbruvica for: