Study on Lenalidomide with Modified DA-EPOCH and Rituximab for Treating Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02911142

Provider View

This clinical trial is testing a new treatment combination using lenalidomide, chemotherapy, and rituximab to see if it can effectively treat Primary Effusion Lymphoma (PEL) or KSHV-associated Large Cell Lymphoma, which are rare and aggressive cancers.

Patient Parameters

Program Overview

Primary Effusion Lymphoma (PEL) is a rare cancer with no standard treatment. This study aims to test if lenalidomide, combined with common chemotherapy drugs and rituximab, can be effective in treating PEL. Participants will undergo various tests and procedures to evaluate their disease and response to the treatment. The study is open to adults aged 18 and older with PEL.

Description

Primary Effusion Lymphoma (PEL) is a rare and aggressive type of cancer associated with the Kaposi sarcoma herpesvirus (KSHV). There is currently no standard treatment for PEL, and the prognosis is often poor. This study is exploring a new treatment approach using lenalidomide, a drug that can modify the immune system, along with a combination of chemotherapy drugs and rituximab, an antibody treatment.

The study is divided into two phases. Phase I will focus on determining the safety and appropriate dosage of lenalidomide when used with the chemotherapy regimen DA-EPOCH-R. Phase II will evaluate the overall survival of participants receiving this treatment combination.

Participants will take lenalidomide pills for 10 days and receive chemotherapy through a catheter placed in a large vein. They will also receive injections of filgrastim and methotrexate to support their treatment. Throughout the study, participants will undergo regular tests, including blood tests, scans, and lumbar punctures, to monitor their health and the effectiveness of the treatment.

The study will follow participants for up to five years, with regular follow-up visits to assess their condition and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with confirmed KSHV-positive aggressive B cell lymphomas, such as Primary Effusion Lymphoma (PEL) or KSHV-associated Large Cell Lymphoma.
  • Lymphoma must be measurable or assessable.
  • Any HIV status is acceptable.
  • Must have blood and organ function within specified limits.
  • Must agree to use effective birth control if of childbearing potential.
  • Must not be pregnant or breastfeeding.
  • Must be able to take aspirin or a similar blood-thinning medication.
  • Must be willing to sign an informed consent document and comply with study requirements.

Exclusion Criteria

  • Use of other cancer treatments within the past two weeks, except for certain allowed medications.
  • Previous treatment with dose-adjusted EPOCH for PEL or KSHV-associated Large Cell Lymphoma.
  • Brain involvement with lymphoma.
  • History of other cancers unless in remission for at least one year or certain non-threatening cancers.
  • Poor kidney or liver function.
  • Low blood cell counts unless related to lymphoma.
  • Severe neuropathy or heart issues.
  • Known blood clotting disorders.
  • Allergic reactions to lenalidomide or similar drugs.
  • Severe uncontrolled illnesses or conditions that would interfere with the study.
  • Pregnant women due to potential risks to the fetus.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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