CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 447 target
Drug / intervention
revumenib +1 moredrug
Likely dose
cobicistat 150 mgfrom record
Key inclusion· 7
  • ✓Active acute leukemia with bone marrow blasts ≥5% or reappearance of blasts in peripheral blood, or acute leukemia with KMT2A rearrangement, NUP98 rearrangement, or NPM1 mutation with detectable disease in bone marrow
  • ✓Phase 2: Documented relapsed/refractory active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood)
  • ✓White blood cell count below 25,000/microliter at time of enrollment
  • ✓Age ≥30 days old; ≥35 kg if receiving cobicistat; ≥18 years and ≥40 kg for Cohort 2D
Key exclusion· 13
  • ✕Diagnosis of active acute promyelocytic leukemia
  • ✕Isolated extramedullary relapse (Phase 2 Cohorts 2A-2C only)
  • ✕Active central nervous system disease (cytologic or radiographic)
  • ✕Detectable HIV viral load within previous 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04065399
NCT04065399Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
CompareCT.gov

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Syndax Pharmaceuticals·interventional·Posted Aug 22, 2019·Updated Mar 18, 2026

In Brief

A Phase 2 clinical trial evaluating revumenib and cobicistat for Acute Myeloid Leukemia and 4 related conditions. Currently recruiting, targeting 447 participants across 57 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
CountriesAustralia, Canada, France, Germany, Israel, Italy, Lithuania, Netherlands, Puerto Rico, Spain, United States
Collaborators--

Timeline

Phase 2Recruiting
202020212022202320242025202620272028
First PostedAug 22, 2019
Enrollment StartNov 5, 2019
Primary CompletionDec 15, 2027
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 6.9 years agoPrimary completion in 1.5 years

Interventions

revumenibdrug

revumenib orally

cobicistatdrug

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