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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

July 3, 2017

Primary Completion Date

October 1, 2024

Study Completion Date

October 1, 2027

Conditions
Primary Effusion LymphomaB-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

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02911142 - Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-associated Large Cell Lymphoma | Biotech Hunter | Biotech Hunter