Recruiting

Phase 1

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

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05389423

Conditions

Diffuse Large Cell Lymphoma

Non-Hodgkin Lymphoma

Burkitt Lymphoma

Plasmablastic Lymphoma

B-Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vincristine

Prednisone

Doxorubicin

Etoposide

Pomalidomide

Study Details

Brief 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....

Conditions

Diffuse Large Cell Lymphoma

Non-Hodgkin Lymphoma

Burkitt Lymphoma

Plasmablastic Lymphoma

B-Cell Neoplasm

Study ID

NCT05389423

Start date

Jun 27, 2023

Status verified date

Aug 21, 2026

Completion date

Jun 1, 2032

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:
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 CRITERIA:

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).

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1/Dose Escalation

Pomalidomide (escalating doses) + Prednisone, Etoposide, Doxorubicin, Vincristin

experimental: 2/Dose Expansion

Pomalidomide (at the MTD) + Prednisone, Etoposide, Doxorubicin, Vincristine and

Interventions

Vincristine

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

Prednisone

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

Doxorubicin

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

Etoposide

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

Pomalidomide

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.

Cyclophosphamide

750 mg/m2 administered IV on day 5

Rituximab

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

Primary outcome measure

safety and tolerability [ Time Frame: 6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal ]

Central Contacts and Locations

Central contacts

Irene B Ekwede, R.N.

(240) 760-6126 ekwedeib@mail.nih.gov

Ramya M Ramaswami, M.D.

(240) 506-1088 ramya.ramaswami@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 25, 2026

Last verified

Aug 21, 2026

Keywords

Non-Hodgkin Lymphoma
Epstein Barr Virus
Plasmablastic Lymphoma
Chemotherapy
Immune Modulatory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-25.