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

Recruiting now · Phase 1

Conditions studied: Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma, Burkitt Lymphoma, Plasmablastic Lymphoma, B-Cell Neoplasm

In brief

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....

Key facts

Study ID: NCT05389423
Run by: National Cancer Institute (NCI)
People needed: 25
Starts: 2023-06-27
Expected to finish: 2032-06-01
Last updated by the study team: 2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Individuals may not receive investigational agents on other clinical trials.
Requirement of any of the agents listed as prohibited thearapies.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.
Parenchymal brain involvement with lymphoma.
Ejection fraction less than 40% by echocardiography (ECHO)
CTCAEv5.0 Grade 3-4 neuropathy
History of malignant tumors other than KS or KSHV-associated multicentric Castleman Disease, (MCD), unless:
In complete remission for >= 1 year from the time response was first documented; or,
Completely resected basal cell carcinoma; or,
In situ squamous cell carcinoma of the cervix or anus; or,
Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.
Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
Symptomatic congestive heart failure
Unstable angina pectoris, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment.
Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.
Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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