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NCT04065399 · ClinicalTrials.gov record · last posted 2026-03-18

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

Study acronym: AUGMENT-101
StatusRecruiting
PhasePhase 1/2
Started2019-11-05
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from the ClinicalTrials.gov record
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.

Amendment record 26 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 26 times since 2019-08-20; most recent amendment 2026-03-17. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2019-09-12
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT04065399
Lead Sponsor Syndax Pharmaceuticals
Conditions Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
Enrollment 447 participants
Start Date 2019-11-05
Primary Completion 2027-12-15 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-18