Trial · NCT04065399
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
NCT04065399, Phase 1, Phase 2, Recruiting, Syndax Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation. Trials, record NCT04065399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04065399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
- NCT number
- NCT04065399
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 447 participants, estimated
- Lead sponsor
- Syndax Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
- Interventions
- revumenib, cobicistat
- First posted
- 2019-08-22
- Last updated
- 2026-10-09
- Other registries' IDs
- eudract:2020-004104-34
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with dose-limiting toxicities (DLTs) (Phase 1) | Approximately 1 year | Assessed by the NCI CTCAE version 5.0 (Phase 1) |
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1) | Approximately 1 year | Assessed by the NCI CTCAE version 5.0 (Phase 1) |
| Primary | Cmax (Phase 1) | Approximately 1 year | Maximum plasma concentration (Cmax) of revumenib and relevant metabolites (Phase 1) |
| Primary | Tmax (Phase 1) | Approximately 1 year | Time to observed maximum plasma concentration of revumenib and relevant metabolites (Phase 1) |
| Primary | AUC0-t (Phase 1) | Approximately 1 year | Area under the plasma concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of revumenib and relevant metabolites (Phase 1) |
| Primary | CR+CRh rate (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | To assess the complete remission (CR) and complete remission with partial hematologic recovery (CRh) rate (Phase 2 \[Cohorts 2A-2C\]) |
| Primary | Number of participants with TEAEs (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | Assessed by the NCI CTCAE version 5.0 (Phase 2 \[Cohorts 2A-2C\]) |
| Primary | Cmax (Phase 2 [Cohort 2D]) | Approximately 3 years | Cmax of revumenib (Phase 2 \[Cohort 2D\]) |
| Primary | AUC0-tau (Phase 2 [Cohort 2D]) | Approximately 3 years | Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau) of revumenib (Phase 2 \[Cohort 2D\]) |
| Secondary | Transfusion independence (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | Transfusion independence is defined as any transfusion-free period lasting for at least 56 consecutive days |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04065399
GET https://conductscience.org/api/trials/v1/NCT04065399/registered