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Revumenib in Combination With 7+3 + Midostaurin in AML

NCT06313437 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-25

No results posted yet for this study

Summary

This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).

The names of the study drugs involved in this study are:

* Revumenib (SNDX-5613) (a type of menin inhibitor)
* Midostaurin (a type of multi-kinase including FLT3 inhibitor)
* Cytarabine (a type of antineoplastic agent)
* Daunorubicin (a type of antineoplastic agent)

Conditions

Interventions

DRUG

Revumenib

Menin inhibitor, 25 and 113 mg capsules, taken orally per protocol.

DRUG

Midostaurin

Kinase inhibitor, capsule taken orally per protocol.

DRUG

Cytarabine

Antineoplastic agent, via intravenous (into the vein) infusion per protocol.

DRUG

Daunorubicin

Antineoplastic agent, via intravenous (into the vein) infusion per protocol.

Sponsors & Collaborators

Principal Investigators

  • Richard Stone, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2027-03-02
Completion
2028-03-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06313437 on ClinicalTrials.gov