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NCT05389423 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
A Phase 1 study of Non-Hodgkin Lymphoma and Burkitt Lymphoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05389423: Recruiting Phase 1 study of Non-Hodgkin Lymphoma and Burkitt Lymphoma, sponsored by National Cancer Institute (NCI).
NCT05389423 is a Phase 1 study of Non-Hodgkin Lymphoma and Burkitt Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants, below the 168-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05389423, a Phase 1 study of Non-Hodgkin Lymphoma and Burkitt Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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....
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Etoposide
- DRUG Vincristine
- DRUG Prednisone
- DRUG Pomalidomide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2032-06-01 |
| Phase | Phase 1 |
What NCT05389423 shows while recruiting
NCT05389423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 168-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (85% lower).
The record links to 5 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.
NCT05389423 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05389423 about?
NCT05389423 is a clinical study titled "Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas". 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 pe...
What is the current status of trial NCT05389423?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-06-27. Estimated completion is 2032-06-01.
What conditions does trial NCT05389423 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, Burkitt Lymphoma, Diffuse Large Cell Lymphoma, Plasmablastic Lymphoma, B-Cell Neoplasm.
What interventions are being tested in trial NCT05389423?
The interventions under investigation include: Doxorubicin (DRUG), Etoposide (DRUG), Vincristine (DRUG), Prednisone (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT05389423?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05389423 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05389423's enrollment target sits among peer trials
25 78th of 106 higher than 27 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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