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

Summary

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.

Conditions

• Primary Effusion Lymphoma
• B-Cell Neoplasm

Interventions

DRUG

Lenalidomide

Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg.

DRUG

Rituximab

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.

DRUG

Prednisone

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.

DRUG

Etoposide

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.

DRUG

Doxorubicin

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.

DRUG

Vincristine

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.

DRUG

Cyclophosphamide

During cycle 1, Cyclophosphamide 750 mg/m\^2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 day 5.

DIAGNOSTIC_TEST

CT of neck, chest, abdomen and pelvis

Screening

DIAGNOSTIC_TEST

18FDG-PET scan

Baseline

DIAGNOSTIC_TEST

MRI Brain

Screening

PROCEDURE

Bone marrow biopsy

Baseline

DIAGNOSTIC_TEST

EKG

Screening

DIAGNOSTIC_TEST

Echocardiogram

Screening

DIAGNOSTIC_TEST

Ultrasound

Day 6

DIAGNOSTIC_TEST

Bronchoscopy

Baseline

DIAGNOSTIC_TEST

Endoscopy

Baseline

DIAGNOSTIC_TEST

CXR: PA/lat/decub

Screening

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Ramya Ramaswami, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-03

Primary Completion

2024-10-01

Completion

2027-10-01

FDA Drug

Yes

Countries

• United States

Study Locations