Trial · NCT06313437
Revumenib in Combination With 7+3 + Midostaurin in AML
NCT06313437, Phase 1, Recruiting, Richard Stone, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Revumenib in Combination With 7+3 + Midostaurin in AML. Trials, record NCT06313437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06313437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Revumenib in Combination With 7+3 + Midostaurin in AML
- NCT number
- NCT06313437
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 22 participants, estimated
- Lead sponsor
- Richard Stone, MD
- Conditions
- Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML, Leukemia
- Interventions
- Revumenib, Midostaurin, Cytarabine, Daunorubicin
- First posted
- 2024-03-15
- Last updated
- 2026-03-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Dose Limiting Toxicity (DLT) | Up to 12 weeks | Detailed DLT consideration outline in protocol section 5.4. |
| Primary | Maximum Tolerated Dose (MTD) | Up to 12 weeks | MTD is determined by the number of patients who experience a DLT. See previous primary outcome measure for the DLT definition. If 0 out of 3 participants experience DLT, next dose level will be proceeded. If \>=1 out of the group suffer DLT, dose escalation will be stopped and 3 additional participants will be entered at the next lowest dose level. If \<=1 out of 6 DLTs, this dose level is considered as MTD. |
| Primary | Recommended phase II dose (RP2D) | Up to 12 weeks | The RP2D is determined by a combination of the MTD (see previous primary outcome measure), pharmacokinetics, pharmacodynamics and response rate to different doses of revumenib in combination with chemotherapy and the FLT3 inhibitor midostaurin. |
| Secondary | Complete Remission (CR) rate with induction chemotherapy | Up to 8 weeks | CR rate is defined as the proportion of participants who achieve a CR as defined by the ELN 2022 response criteria after completion of induction chemotherapy. |
| Secondary | Complete Remission (CR) rate with consolidation chemotherapy | Up to 12 weeks | CR rate is defined as the proportion of participants who achieve a CR as defined by the ELN 2022 response criteria after completion of consolidation chemotherapy. |
| Secondary | Flow Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy | Up to 8 weeks | Flow MRD rate is defined as the proportion of participants who achieve MRD negativity (MRD-) after completion of induction chemotherapy assessed by MRD sensitive flow cytometry. |
| Secondary | Flow Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy | Up to 12 weeks | Flow MRD rate is defined as the proportion of participants who achieve MRD negativity (MRD-) after completion of consolidation chemotherapy assessed by MRD sensitive flow cytometry. |
| Secondary | Molecular Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy | Up to 8 weeks | Molecular MRD rate is defined as the proportion of participants who achieve MRD negativity (MRD-) after completion of induction chemotherapy as assessed by NPM1 MRD testing as well as FLT3 ITD MRD testing and duplex sequencing. |
| Secondary | Molecular Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy | Up to 12 weeks | Molecular MRD rate is defined as the proportion of participants who achieve MRD negativity (MRD-) after completion of consolidation chemotherapy as assessed by NPM1 MRD testing as well as FLT3 ITD MRD testing and duplex sequencing. |
| Secondary | Relapse-Free Survival at 1 year (RFS1) | Up to 1 year | RFS is defined as the length of time after the completion of a particular medical treatment during which a patient remains free of any signs or symptoms of disease relapse or recurrence based on Kaplan-Meier methodology. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06313437
GET https://conductscience.org/api/trials/v1/NCT06313437/registered