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NCT07411586 · ClinicalTrials.gov registry record · Phase 1
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07411586: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT07411586 is a Phase 1 study that has not yet begun recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07411586, a Phase 1 study, has not yet begun recruiting, sponsored by M.D. Anderson Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes. The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control the disease. The safety and effects of this combination will also be studied in both parts.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Interventions
- DRUG Olutasidenib
- DRUG Ziftomenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-08-31 |
| Est. Completion | 2029-01-14 |
| Phase | Phase 1 |
What is known before NCT07411586 opens enrollment
NCT07411586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Olutasidenib is the first listed.
NCT07411586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07411586 about?
NCT07411586 is a clinical study titled "Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia". The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes. The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control th...
What is the current status of trial NCT07411586?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-08-31. Estimated completion is 2029-01-14.
What interventions are being tested in trial NCT07411586?
The interventions under investigation include: Olutasidenib (DRUG), Ziftomenib (DRUG).
Who is sponsoring clinical trial NCT07411586?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07411586's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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