Clinical Trial: NCT04065399
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Syndax Pharmaceuticals |
| Information Provided By: | Syndax Pharmaceuticals |
| Last Update Posted: | 2026-10-09 |
Study Overview
Brief 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.
Official Title
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
Conditions
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
Intervention / Treatment
- Drug: revumenib
- Drug: cobicistat
Other Study ID Numbers
- SNDX-5613-0700
- 2020-004104-34
Start Date (Actual)
2019-11-05
Primary Completion Date (Estimated)
2027-12-15
Study Completion Date (Estimated)
2027-12-15
Enrollment (Estimated)
447
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Syndax Pharmaceuticals |
| Information Provided By: | Syndax Pharmaceuticals |
| Last Update Posted: | 2026-10-09 |
Study Overview
Brief 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.
Official Title
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
Conditions
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
Intervention / Treatment
- Drug: revumenib
- Drug: cobicistat
Other Study ID Numbers
- SNDX-5613-0700
- 2020-004104-34
Start Date (Actual)
2019-11-05
Primary Completion Date (Estimated)
2027-12-15
Study Completion Date (Estimated)
2027-12-15
Enrollment (Estimated)
447
Study Type
Interventional
Phase
Phase 1, Phase 2