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A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
NCT04065399 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04065399
The ClinicalTrials.gov registry entry for NCT04065399 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syndax Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04065399 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04065399?
The interventions under investigation include: revumenib (DRUG), cobicistat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04065399?
This trial is sponsored by Syndax Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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