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Kinase Inhibitor

Rituximab + Lenalidomide + Ibrutinib for Follicular Lymphoma

Phase 1

Waitlist Available

Led By Chaitra S Ujjani

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

- Lymphangitis cutis/pulmonis

- Ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of two drugs, lenalidomide and ibrutinib, when given with a third drug, rituximab, to treat patients with follicular lymphoma that has not been treated before.

Who is the study for?

This trial is for adults with previously untreated stage II-IV follicular lymphoma. Eligible participants must have a certain level of health, including no severe heart conditions, uncontrolled seizures, or active infections like HIV above specific thresholds. They should not be pregnant or nursing and must agree to use effective birth control methods.

What is being tested?

The study tests the combination of lenalidomide and ibrutinib with rituximab to treat follicular lymphoma. Lenalidomide may help the immune system halt cancer growth; ibrutinib blocks enzymes needed by cancer cells; rituximab targets CD20 on B cells and some cancers.

What are the potential side effects?

Potential side effects include immune system reactions, organ inflammation due to rituximab's targeting of B cells, possible blood disorders from lenalidomide affecting cell growth regulation, and enzyme inhibition-related issues caused by ibrutinib.

Eligibility Criteria

Inclusion Criteria

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

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I have lymphangitis in my skin or lungs.

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I have fluid buildup in my abdomen.

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I have fluid around my lungs or heart.

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My heart rhythm is stable and controlled.

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I do not have heart failure.

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My follicular lymphoma is classified with 0-5 FLIPI risk factors.

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My cervical cancer was treated and shows no signs of being present now.

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I do not have any serious heart conditions.

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I have a specific type of lymphoma that has not been treated and needs therapy.

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My cancer cells test positive for CD20.

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I have not had any treatment for non-Hodgkin lymphoma.

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I have never taken the drugs being tested in this study.

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I have a tumor larger than 1 cm or my cancer can be measured by tests.

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My HIV viral load is under 10,000 copies/mL without HIV treatment.

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I am not taking strong medications that affect liver enzymes.

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My lymphoma has not spread to my brain or spinal cord.

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I have not taken strong drugs that affect liver enzymes recently.

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I have never had seizures that couldn't be controlled.

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I do not have an autoimmune disorder needing immunosuppressants.

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My heart condition does not severely limit my daily activities.

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My cancer was treated over 3 years ago, and my doctor believes it's unlikely to come back.

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I had skin cancer (not melanoma) or lentigo maligna melanoma, but it's now treated with no signs of the disease.

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I am 18 years old or older.

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My white blood cell count is healthy without needing medication or transfusions for the past week.

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My kidneys work well, with a creatinine clearance over 60 mL/min.

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I can take care of myself and am up and about more than half of the day.

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I have never had an AIDS-defining condition.

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My HIV is well-controlled with medication.

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I do not need blood transfusions for low platelet counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Rituximab

Secondary study objectives

Complete response rate

Overall response rate

Overall survival (OS)

+2 more

Other study objectives

BTK parameters

Pharmacokinetic parameters of ibrutinib and major metabolite PCI-45227

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, and rituximab)Experimental Treatment5 Interventions

Patients receive lenalidomide PO QD on days 1-21 and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, 15, and 22 of cycle 1 and once weekly at weeks 13, 21, 29, and 37.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Ibrutinib

2014

Completed Phase 4

~2060