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NCT06397027 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
A Phase 1 study of Refractory Acute Leukemia and Pediatric Relapsed, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT06397027: Recruiting Phase 1 study of Refractory Acute Leukemia and Pediatric Relapsed, sponsored by M.D. Anderson Cancer Center.
NCT06397027 is a Phase 1 study of Refractory Acute Leukemia and Pediatric Relapsed that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 36-participant average among 3 other Refractory Acute Leukemia trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06397027, a Phase 1 study of Refractory Acute Leukemia and Pediatric Relapsed, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Ziftomenib
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-12-27 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
What NCT06397027 shows while recruiting
NCT06397027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 36-participant average among 3 other Refractory Acute Leukemia trials with a reported enrollment target (39% lower).
The record links to 2 conditions, with Refractory Acute Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06397027 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06397027 about?
NCT06397027 is a clinical study titled "A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias". To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).
What is the current status of trial NCT06397027?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2024-12-27. Estimated completion is 2030-12-31.
What conditions does trial NCT06397027 study?
This clinical trial studies the following conditions: Refractory Acute Leukemia, Pediatric Relapsed.
What interventions are being tested in trial NCT06397027?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Ziftomenib (DRUG).
Who is sponsoring clinical trial NCT06397027?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06397027 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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