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NCT07304011 · ClinicalTrials.gov registry record · Phase 2
Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent
A Phase 2 study of Acute Myeloid Leukemia, sponsored by University of California, Davis.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT07304011: Recruiting Phase 2 study of Acute Myeloid Leukemia, sponsored by University of California, Davis.
NCT07304011 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 28 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07304011, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.
Primary Outcome
Defined as the percent of patients who reached death due to acute myeloid leukemia (AML), relapse, or discontinuation of treatment due to an adverse event, at 12 months from the time of CR/CRi in patients with AML who begin first line venetoclax plus a hypomethylating agent regimen and subsequently transition to olutasidenib maintenance. The Kaplan-Meier method will be employed to summarize the duration from the initiation of study treatment to treatment failure and to report the probability of
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Olutasidenib
Study Locations (1)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2025-12-17 |
| Est. Completion | 2032-01-01 |
| Phase | Phase 2 |
What NCT07304011 shows while recruiting
NCT07304011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT07304011 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07304011 about?
NCT07304011 is a clinical study titled "Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent". This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacit...
What is the current status of trial NCT07304011?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2025-12-17. Estimated completion is 2032-01-01.
What conditions does trial NCT07304011 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT07304011?
The interventions under investigation include: Azacitidine (DRUG), Olutasidenib (DRUG).
Who is sponsoring clinical trial NCT07304011?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07304011 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07304011's enrollment target sits among peer trials
28 213th of 306 higher than 93 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
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