Rituximab + Lenalidomide + Ibrutinib for Follicular Lymphoma

Palo Alto (17 mi)

Overseen byChaitra S Ujjani

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 when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.

Eligibility Criteria

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.

Inclusion Criteria

I have lymphangitis in my skin or lungs.

I have fluid buildup in my abdomen.

I have fluid around my lungs or heart.

My heart rhythm is stable and controlled.

I do not have heart failure.

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

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

I do not have any serious heart conditions.

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

My cancer cells test positive for CD20.

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

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

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

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

I am not taking strong medications that affect liver enzymes.

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

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

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

I do not have an autoimmune disorder needing immunosuppressants.

My heart condition does not severely limit my daily activities.

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

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

I am 18 years old or older.

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

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

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

I have never had an AIDS-defining condition.

My HIV is well-controlled with medication.

I do not need blood transfusions for low platelet counts.

Treatment Details

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.

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.

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

🇪🇺 Approved in European Union as Imbruvica for: