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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05389423
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-Cell Neoplasm
  • Burkitt Lymphoma
  • Diffuse Large Cell Lymphoma
  • Non-Hodgkin Lymphoma
  • Plasmablastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    0.4 mg/m2/day administered by CIVI on days 1 to 4
  • Prednisone — DRUG
    60 mg/m2/day administered orally on days 1 to 5
  • Doxorubicin — DRUG
    10 mg/m2/day administered by CIVI on days 1 to 4
  • Etoposide — DRUG
    50 mg/m2/day administered by CIVI on days 1 to 4
  • Pomalidomide — DRUG
    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 — DRUG
    750 mg/m2 administered IV on day 5
  • Rituximab — DRUG
    375 mg/m2 administered IV on day 1 (only for CD20+ tumors)

Study Details

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 Dates

Start date
Jun 27, 2023
Status verified
May 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2032

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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