Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas

Summary

Background:

Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating

people with both HIV and NHL.

Objective:

To test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.

Eligibility:

Adults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.

Design:

Individuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed.

Individuals will receive up to 6 cycles of treatment.

The first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.

The remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.

Screening tests will be repeated at study visits.

Follow-up visits will continue for 4 years....

Conditions

• Diffuse Large Cell Lymphoma
• Non-Hodgkin Lymphoma
• Burkitt Lymphoma
• Plasmablastic Lymphoma
• B-Cell Neoplasm

Interventions

DRUG

Vincristine

0.4 mg/m2/day administered by CIVI on days 1 to 4

DRUG

Prednisone

60 mg/m2/day administered orally on days 1 to 5

DRUG

Doxorubicin

10 mg/m2/day administered by CIVI on days 1 to 4

DRUG

Etoposide

50 mg/m2/day administered by CIVI on days 1 to 4

DRUG

Pomalidomide

An initial dose of 3mg administered orally for 10 days in all cycles. In cycle 1, it will start 5 days before DA-EPOCH; in cycles 2-6, it will start on day 1. Administered at an MTD dose for the expansion phase.

DRUG

Cyclophosphamide

750 mg/m2 administered IV on day 5

DRUG

Rituximab

375 mg/m2 administered IV on day 1 (only for CD20+ tumors)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-27

Primary Completion

2028-06-01

Completion

2032-06-01

FDA Drug

Yes

Countries

• United States

Study Locations