RecruitingPhase 1NCT05389423

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

Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas


Sponsor

National Cancer Institute (NCI)

Enrollment

25 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

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....


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination regimen — pomalidomide plus dose-adjusted EPOCH chemotherapy, with or without rituximab — for HIV-positive people with aggressive B-cell non-Hodgkin lymphoma (a blood cancer that can be more common and harder to treat in people living with HIV). The aim is to improve outcomes for this high-risk population. **You may be eligible if...** - You have been diagnosed with B-cell non-Hodgkin lymphoma, confirmed by biopsy - You are HIV-positive - Your lymphoma has specific features such as involvement of the nervous system or spinal fluid, or certain high-risk genetic characteristics - You are able to give informed consent and attend follow-up **You may NOT be eligible if...** - You have serious uncontrolled infections or medical conditions that would make treatment unsafe - You are pregnant or breastfeeding - Your liver, kidney, or heart function is too compromised to safely receive intensive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVincristine

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

DRUGPrednisone

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

DRUGDoxorubicin

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

DRUGEtoposide

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

DRUGPomalidomide

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.

DRUGCyclophosphamide

750 mg/m2 administered IV on day 5

DRUGRituximab

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


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT05389423


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