OncoMatch/Clinical Trials/NCT05389423
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Is NCT05389423 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for diffuse large cell lymphoma.
Treatment: Vincristine · Prednisone · Doxorubicin · Etoposide · Pomalidomide · Cyclophosphamide · Rituximab — 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....
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–4(Completely disabled)
Prior therapy
Cannot have received: curative-intent chemotherapy
Exception: prior treatment as a bridge to curative-intent therapy allowed per Protocol Chair discretion if >= 2 weeks since administration; steroids for any reason or rituximab for multicentric Castleman disease allowed any time prior to treatment start
Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if >= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.
Lab requirements
Blood counts
absolute neutrophil count >=1,000/mcL; platelets >=75,000/mcL
Kidney function
creatinine clearance >=60 mL/min/1.73 m^2 for individuals with creatinine levels above institutional normal
Liver function
total bilirubin <=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin <= 5 mg/dL with <80% unconjugated bilirubin); AST/ALT <=3 X institutional upper limit of normal
Cardiac function
ejection fraction >= 40% by echocardiography (ECHO)
Adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator: * absolute neutrophil count >=1,000/mcL * platelets >=75,000/mcL * total bilirubin <=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin <= 5 mg/dL with <80% unconjugated bilirubin) * aspartate aminotransferase (AST) / alanine transaminase (ALT) <=3 X institutional upper limit of normal * creatinine clearance >=60 mL/min/1.73 m^2 for individuals with creatinine levels above institutional normal. Ejection fraction less than 40% by echocardiography (ECHO) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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