Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02911142
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • B-Cell Neoplasm
  • Primary Effusion Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg.
  • Rituximab — DRUG
    During cycle 1, rituximab will be administered on day 4 prior to the start of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH). During cycles 2 to 6, rituximab will be administered on day 1 of each cycle.
  • Prednisone — DRUG
    During cycle 1, Prednisone 60 mg/m\^2 /day by mouth (PO) days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5.
  • Etoposide — DRUG
    During cycle 1, Etoposide 50 mg/m\^2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide 50 mg/m\^2/day continuous intravenous infusion days 1 to 4.
  • Doxorubicin — DRUG
    During cycle 1, Doxorubicin 10 mg /m\^2/day continuous intravenous infusion days 6 to 9. During cycles 2-6, Doxorubicin continuous intravenous infusion days 1 to 4.
  • Vincristine — DRUG
    During cycle 1, Vincristine 0.4 mg/m\^2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Vincristine continuous intravenous infusion days 1 to 4.
  • Cyclophosphamide — DRUG
    During cycle 1, Cyclophosphamide 750 mg/m\^2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 day 5.
  • CT of neck, chest, abdomen and pelvis — DIAGNOSTIC_TEST
    Screening
  • 18FDG-PET scan — DIAGNOSTIC_TEST
    Baseline
  • MRI Brain — DIAGNOSTIC_TEST
    Screening
  • Bone marrow biopsy — PROCEDURE
    Baseline
  • EKG — DIAGNOSTIC_TEST
    Screening
  • Echocardiogram — DIAGNOSTIC_TEST
    Screening
  • Ultrasound — DIAGNOSTIC_TEST
    Day 6
  • Bronchoscopy — DIAGNOSTIC_TEST
    Baseline
  • Endoscopy — DIAGNOSTIC_TEST
    Baseline
  • CXR: PA/lat/decub — DIAGNOSTIC_TEST
    Screening

Study Details

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.

Key Dates

Start date
Jul 3, 2017
Status verified
Jul 2025
Primary completion
Oct 1, 2024
Completion
Oct 1, 2027

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide, Rituximab, Prednisone, Etoposide, Doxorubicin, Vincristine and Cyclophosphamide
    Lenalidomide, Rituximab, Prednisone, Etoposide, Doxorubicin, Vincristine and Cyclophosphamide

Primary Outcome Measure

(Phase I) Maximum Tolerated Dose (MTD) of Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (DA-EPOCH-R2) [ Time Frame: First 6 weeks of treatment (2 cycles of treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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