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NCT04065399 · ClinicalTrials.gov registry record · Phase 1
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Syndax Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 447
- Enrollment target
- 20
- Study locations
NCT04065399: Recruiting Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Syndax Pharmaceuticals.
NCT04065399 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Syndax Pharmaceuticals. The registered enrollment target is 447 participants, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (292% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04065399, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Syndax Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 447 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.
Primary Outcome
Assessed by the NCI CTCAE version 5.0 (Phase 1)
Conditions Studied
Interventions
- DRUG revumenib
- DRUG cobicistat
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital - Los Angeles
- Stanford Cancer Institute - Palo Alto
Florida
- Florida Cancer Specialists and Research Institute - Sarasota
- Moffitt Cancer Center - Tampa
Georgia
- Emory Winship Cancer Institute - Atlanta
- Children's Healthcare of Atlanta - Atlanta
New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center - New York
Ohio
- University of Cincinnati - Cincinnati
- Ohio State University - Columbus
Colorado
- University of Colorado - Aurora
Illinois
- The University of Chicago Medical Center - Chicago
Iowa
- University of Iowa Hospital - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 1 |
What NCT04065399 shows while recruiting
NCT04065399 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (292% higher).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which revumenib is the first listed.
NCT04065399 names 20 study sites across 14 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04065399 about?
NCT04065399 is a clinical study titled "A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation". Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, ...
What is the current status of trial NCT04065399?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 447 participants. The study started on 2019-11-05. Estimated completion is 2027-12-15.
What conditions does trial NCT04065399 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Mixed Lineage Acute Leukemia.
What interventions are being tested in trial NCT04065399?
The interventions under investigation include: revumenib (DRUG), cobicistat (DRUG).
Who is sponsoring clinical trial NCT04065399?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04065399 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04065399's enrollment target sits among peer trials
447 11th of 306 higher than 296 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.
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