Pomalidomide and Chemotherapy for HIV-Associated Lymphomas
This study is testing a new combination of treatments for people with HIV-associated non-Hodgkin lymphoma (NHL), specifically diffuse large cell lymphoma, Burkitt lymphoma, or plasmablastic lymphoma. The study combines pomalidomide with a chemotherapy regimen called DA-EPOCH (which includes vincristine, prednisone, doxorubicin, and etoposide). Some participants may also receive rituximab. The main goal is to understand how safe and tolerable this treatment combination is. You might be able to join if you are an adult (18 or older) with HIV-associated B-cell NHL that has high-risk features, such as involvement of the brain or spinal cord, or certain types of lymphoma like plasmablastic histology. The study is currently unclear on its recruitment status and plans to enroll 25 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is designed to test the safety and tolerability of the treatment combination.
- What's involved
- You will undergo screening, including a physical exam, blood and urine tests, heart function tests, and possibly imaging scans. Treatment cycles will involve pomalidomide for 10 days and DA-EPOCH chemotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be measured for up to 6 cycles of treatment, or until your lymphoma progresses, you experience unacceptable side effects, or you withdraw from the study.
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NCT05389423
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~25 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:VincristinePrednisoneDoxorubicinEtoposidePomalidomideCyclophosphamide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
safety and tolerability
Measured over 6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Ramya M Ramaswami, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:
Leptomeningeal/CSF involvement
High-risk for CNS relapse per CNS-IPI (score 4-6)
Plasmablastic histology
Gamma herpesvirus positive tumor
Presence of KS
Measurable or evaluable lymphoma.
Positive HIV1/2 serology.
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.
Age \>=18 years
Eastern Cooperative Oncology Group performance status (ECOG-PS) \<=4
Individuals of childbearing potential (IOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 2 weeks prior to and again within 1 day before starting the study drugs and must either commit to continued abstinence from penetrative vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy.
Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.
All individuals must agree to be registered into the mandatory POMALYST REMS(R)TM program and be willing and able to comply with the requirements of the POMALYST REMS(R)TM program.
Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.
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.
Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.
Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART).
Individuals must understand and sign a written informed consent document.
Exclusion
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).
What this trial measures
- safety and tolerability6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal
The fraction of individuals with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.