Actively Recruiting
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
466 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma with one or more high-risk features
- Measurable or evaluable lymphoma
- Positive HIV1/2 serology
- No prior curative-intent chemotherapy for lymphoma (exceptions considered by Protocol Chair)
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 4 or less
- Negative pregnancy test for individuals who can become pregnant and agreement to use effective birth control
- Agreement to use effective contraception for individuals able to father a child
- Agreement to participate in the POMALYST REMS(R) program
- Ability to take daily aspirin 81mg or an alternative thromboprophylaxis
- Adequate organ and marrow function unless abnormalities are due to lymphoma or HIV
- Hepatitis B infection must be on suppressive antiviral therapy
- Willingness to take and adhere to antiretroviral therapy
- Ability to understand and sign informed consent
You will not qualify if you...
- Participation in other clinical trials with investigational agents
- Use of prohibited therapies
- History of allergic reactions to pomalidomide or similar agents
- Parenchymal brain involvement with lymphoma
- Ejection fraction less than 40% by echocardiography
- Grade 3-4 neuropathy per CTCAEv5.0
- History of other malignant tumors except Kaposi sarcoma or KSHV-associated multicentric Castleman Disease unless in remission or fully resected
- Known procoagulant disorders except certain mutations or conditions without other criteria
- Symptomatic congestive heart failure
- Unstable angina, symptomatic or medically treated cardiac arrhythmia
- Uncontrolled serious medical illness or infection excluding lymphoma or HIV
- Pregnant or nursing individuals (must agree not to nurse while taking pomalidomide)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anaida Widell
CONTACT
R
Ramya M Ramaswami, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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