OncoMatch/Clinical Trials/NCT04065399
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Is NCT04065399 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including revumenib and cobicistat for acute myeloid leukemia.
Treatment: revumenib · cobicistat — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Required: NPM1 mutation
Required: NUP98 rearrangement
Performance status
ECOG OR KARNOFSKY/LANSKY 0–2
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
QTc ≤450 ms; no recent (6 months) MI, unstable angina, CHF (NYHA ≥II), life-threatening arrhythmia, CVA, or TIA
Adequate organ function. Cardiac Disease: Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack. Corrected QT interval (QTc) >450 milliseconds.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital · Los Angeles, California
- Stanford Cancer Institute · Palo Alto, California
- University of Colorado · Aurora, Colorado
- Florida Cancer Specialists and Research Institute · Sarasota, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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