A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
← catalyst calendarNCT04065399 · readout in 483 d
Sponsored by Syndax Pharmaceuticals (industry) · SNDX — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
447estimated
Sites
57
Countries
Australia, Canada, France +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-11-05 | actual | When the study began enrolling |
| Primary completion | 2027-12-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-15 | estimated | The whole study's end, after follow-up |
| First posted | 2019-08-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Mixed Lineage Acute Leukemia
- Mixed Phenotype Acute Leukemia
- Acute Leukemia of Ambiguous Lineage
Interventions
- Drug: revumenib — also filed as SNDX-5613
- Drug: cobicistat
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with dose-limiting toxicities (DLTs) (Phase 1)
measured Approximately 1 year
Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1)
measured Approximately 1 year
Cmax (Phase 1)
measured Approximately 1 year
Tmax (Phase 1)
measured Approximately 1 year
AUC0-t (Phase 1)
measured Approximately 1 year
CR+CRh rate (Phase 2 [Cohorts 2A-2C])
measured Approximately 3 years
Number of participants with TEAEs (Phase 2 [Cohorts 2A-2C])
measured Approximately 3 years
Cmax (Phase 2 [Cohort 2D])
measured Approximately 3 years
AUC0-tau (Phase 2 [Cohort 2D])
measured Approximately 3 years
Publications
- PMID 41621809 — linked by the registry
- PMID 40332046 — linked by the registry
- PMID 39121437 — linked by the registry
- PMID 36922593 — linked by the registry
- PMID 34267079 — linked by the registry
- PMID 33741715 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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