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NCT04277442 · ClinicalTrials.gov registry record · Phase 1
Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04277442: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04277442 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04277442, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This trial studies the side effects of nivolumab in combination with decitabine and venetoclax and to see how well they work in treating patients with TP53-mutated acute myeloid leukemia. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study is being done to find out whether giving nivolumab, decitabine, and venetoclax is better or worse than the usual approach for TP53-mutated acute myeloid leukemia.
Primary Outcome
Toxicity will be graded and reported according to the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Interventions
- DRUG Venetoclax
- DRUG Decitabine
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2022-09-06 |
| Phase | Phase 1 |
What the finished NCT04277442 record still lists
NCT04277442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04277442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04277442 about?
NCT04277442 is a clinical study titled "Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia". This trial studies the side effects of nivolumab in combination with decitabine and venetoclax and to see how well they work in treating patients with TP53-mutated acute myeloid leukemia. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer...
What is the current status of trial NCT04277442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-03-11. Estimated completion is 2022-09-06.
What interventions are being tested in trial NCT04277442?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04277442?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04277442's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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