RecruitingPhase 1

Revumenib in Combination With 7+3 + Midostaurin in AML

United States22 participantsStarted 2024-12-06

Plain-language 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)

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with AML who are newly diagnosed according to the WHO 2022 Classification and previously untreated except for hydroxyurea. ATRA pretreatment for suspected APL for less than 5 days is allowed. Eligible patients with AML arising from an antecedent hematologic disease (AHD) including MDS, may have been treated for their prior hematologic disease (except for allogenic transplant). * Patients must be ≥ 18 and \< 75 years old. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. * Presence of FLT3-ITD and/or TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood * Dose escalation phase only: Presence of any of the following adverse risk genetic characteristics: * 2022 ELN adverse risk genetic features: * t(6;9)(p23.3;q34.1)/DEK::NUP214 * t(v;11q23.3)/KMT2A-rearranged * t(9;22)(q34.1;q11.2)/BCR::ABL1 * t(8;16)(p11.2;p13.3)/KAT6A::CREBBP * inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/ GATA2, MECOM(EVI1) * t(3q26.2;v)/MECOM(EVI1)-rearranged * -5 or del(5q); -7; -17/abn(17p) * Complex karyotype, monosomal karyotype * Mutations in either one of these genes: ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2 * Mutated TP53 * NPM1 + FLT3-ITD + DNMT3A mutation * LVEF ≥ 50% by MUGA or ECHO at screening. * Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min; determined by the Cockcroft Gault formula. * Adequate liver function as de…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Timeframe: Up to 12 weeks

Maximum Tolerated Dose (MTD)

Timeframe: Up to 12 weeks

Recommended phase II dose (RP2D)

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT06313437

SponsorRichard Stone, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-02

Contact for this trial

Richard Stone, MD

617-632-5157 richard_stone@dfci.harvard.edu

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.