MedTrace Logo

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2026-03-18

No results posted yet for this 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

Interventions

DRUG

revumenib

revumenib orally

DRUG

cobicistat

Phase 1 Arm C participants will receive 150 mg cobicistat daily.

Sponsors & Collaborators

Principal Investigators

  • Angela R Smith, M.D. · Syndax Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2027-12-15
Completion
2027-12-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04065399 on ClinicalTrials.gov