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

ConditionsDiffuse Large Cell LymphomaNon-Hodgkin LymphomaBurkitt LymphomaPlasmablastic LymphomaB-Cell Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

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....

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Leptomeningeal/CSF involvement

High-risk for CNS relapse per CNS-IPI (score 4-6)

Plasmablastic histology

Gamma herpesvirus positive tumor

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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)

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: 1/Dose EscalationExperimental treatment 7 interventions
Group B: 2/Dose ExpansionExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

safety and tolerability

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.

Time frame
6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal

Secondary outcomes

1

progression-free survival

duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first

Time frame
every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
2

preliminary estimates of response

Percentage of individuals with the best overall response of CR or PR to therapy

Time frame
every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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