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NCT05371054 · ClinicalTrials.gov registry record · Phase 1
Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05371054: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT05371054 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05371054, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: Non-Hodgkin lymphomas are blood cancers that can be difficult to treat. They can also return after treatment. Examples include diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). More effective treatments are needed for these diseases. Objective: To test the safety of a study drug (Enitociclib (VIP152) in combination with other drugs used to treat people with aggressive blood cancers. Eligibility: People aged 18 years or older diagnosed with DLBCL, PTCL, or related blood cancers. The cancers must have either not responded to treatment or returned after treatment. Design: Participants will undergo screening. They will have a physical exam with scans and blood and urine tests. They will have imaging scans and tests of their heart function. They may also provide a bone marrow aspiration or biopsy. Participants may provide a saliva sample for deoxyribonucleic acid (DNA) testing. Participants will receive study treatment in cycles. Each cycle is 21 days. Participants will take two drugs by mouth at home once a day on days 1-10 of each cycle. On days 2 and 9 they will come to the clinic to receive VIP152. This drug will be administered through a small plastic tube with a needle placed in a vein. On day 11, participants will receive a fourth medication as an injection under the skin. They will rest and recover on days 12-21. Screening tests will be repeated periodically throughout the study period. Treatment will continue for up to 24 cycles. Participants will have follow-up visits for up to 5 years.
Interventions
- DRUG Venetoclax
- DRUG Prednisone
- DEVICE Vysis LSI MYC Break Apart Rearrangement Probe Kit
- DRUG VIP152
- DIAGNOSTIC_TEST PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2025-12-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05371054
The ClinicalTrials.gov registry entry for NCT05371054 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Venetoclax is the first listed.
NCT05371054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05371054 about?
NCT05371054 is a clinical study titled "Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies". Background: Non-Hodgkin lymphomas are blood cancers that can be difficult to treat. They can also return after treatment. Examples include diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). More effective treatments are needed for these diseases. Objective: To test the s...
What is the current status of trial NCT05371054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2023-04-05. Estimated completion is 2025-12-16.
What interventions are being tested in trial NCT05371054?
The interventions under investigation include: Venetoclax (DRUG), Prednisone (DRUG), Vysis LSI MYC Break Apart Rearrangement Probe Kit (DEVICE), VIP152 (DRUG), PET (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05371054?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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