← Back to Search

Bruton's Tyrosine Kinase Inhibitor

Lenalidomide + Ibrutinib for Lymphoma

Phase 1

Waitlist Available

Led By Beth A Christian

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Curative therapy must have been exhausted or not feasible to administer

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Patients requiring any therapeutic anticoagulation

Uncontrolled intercurrent illness including ongoing or active infection, or psychiatric illness/social situations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of lenalidomide and ibrutinib for patients with B-cell non-Hodgkin lymphoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include fatigue, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk or bleeding problems, liver function abnormalities, allergic reactions, and possibly heart rhythm disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need medication to prevent blood clots.

Select...

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

Select...

My lymphoma has spread to my brain or spinal cord.

Select...

I am allergic to lenalidomide or similar drugs.

Select...

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

Select...

I have been treated with a BTK inhibitor before.

Select...

I have no lasting side effects from previous cancer treatments.

Select...

I cannot swallow pills or have major digestive issues.

Select...

I have a bleeding disorder or hemophilia.

Select...

I am taking medication that strongly affects liver enzymes.

Select...

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

Select...

I have a serious liver condition.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria

Maximum tolerated dose (MTD)

Secondary study objectives

Degree of response

Duration of overall response

Duration of stable disease

+2 more

Other study objectives

Change in pharmacodynamic markers including TH1 and TH2 cytokines, ex vivo NK cell cytotoxicity, serum microRNAs, plasma metabolites, and levels of Bruton's tyrosine kinase occupancy and other selected kinases

Changes in B- T-, and NK- cell subsets

Changes in quantitative immunoglobulin levels

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160