Lenalidomide + EPOCH-R for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByKathryn A Lurain, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Background: Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers want to see if a drug called lenalidomide along with common chemotherapy drugs may be effective in treating PEL. Objective: To test a new treatment for PEL. Eligibility: People ages 18 and older with PEL. Design: Participants will be screened with blood tests, imaging studies, a physical exam, and other tests. Participants will have tests to evaluate their disease. These may include: Blood tests Scans Lumbar puncture. Fluid around the spinal cord will be removed with a needle. Bone marrow removed with a needle and studied Samples of skin or lymph nodes removed Fluid removed from around organs Lung and eye tests Tubes with cameras taking pictures of airways or digestive tract Participants will take lenalidomide pills for 10 days. They will keep a pill diary. Participants will have a catheter (small tube) placed in the large vein in the arm or chest. Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days. This will be repeated in 21-day cycles. Most participants will have 6 cycles. Participants will get the drug filgrastim by injection under the skin. They will get the drug methotrexate injected into the spinal fluid. During the study, participants will have the following tests done at least once: Medical history Physical exam Blood, urine, and stool tests Lesions photographed and measured Lumbar puncture Participants will have follow-up visits for 5 years. They will repeat the screening tests plus have urine and stool tested. Participants may be contacted later by phone to see how they are doing.

Eligibility Criteria

Adults with primary effusion lymphoma (PEL) or KSHV-associated large cell lymphoma can join this trial. They must have measurable or assessable lymphoma, any HIV status, and be able to take daily aspirin or a substitute. Women of childbearing age must test negative for pregnancy and use two forms of birth control; men must use condoms. Participants cannot have had certain other cancer treatments recently, severe illnesses that could interfere with the study, poor organ function related to conditions other than their lymphoma, or known allergies to similar drugs.

Inclusion Criteria

All study participants must agree to be registered into the mandatory REVLIMID REMS program, and be willing and able to comply with the requirements of the REVLIMID REMS program

I can take aspirin daily or a substitute if I'm allergic.

Ability of subject to understand and the willingness to sign a written informed consent document

+6 more

Exclusion Criteria

My kidney function is low, with a creatinine clearance under 60 mL/min.

You have experienced severe allergic reactions to thalidomide, lenalidomide, or pomalidomide in the past, including a specific type of rash called erythema nodosum.

Any condition, including laboratory abnormalities, which in the opinion of the Principal Investigator or Lead Associate Investigator, would prohibit administration of planned chemotherapeutic intervention, places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study

+13 more

Participant Groups

The trial is testing lenalidomide pills combined with DA-EPOCH-R chemotherapy given through a catheter over several days in cycles lasting 21 days each. Most participants will undergo six cycles. Additional medications like filgrastim and methotrexate are also part of the treatment regimen. The effectiveness of this combination therapy against PEL is being evaluated.

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment7 Interventions

Lenalidomide, Rituximab, Prednisone, Etopiside, Doxorubicin, Vincristine and Cyclophosphamide

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

🇺🇸 Approved in United States as Cytoxan for: