Clin2
NCT05886049Possibly a fitRecruiting

Testing a menin drug with standard chemo for newly diagnosed AML

Acute Myeloid LeukemiaAcute Myeloid Leukemia With KMT2A RearrangementAcute Myeloid Leukemia With NPM1 MutationSecondary Acute Myeloid Leukemia

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This early-phase study tests a menin inhibitor drug (SNDX-5613) combined with standard induction chemotherapy (daunorubicin plus cytarabine) in newly diagnosed AML with specific gene changes (NPM1 or FLT3 status, or MLL/KMT2A or NUP98). It may help patients whose AML has these genetic features respond better to intensive treatment.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
38 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • You are 18–75 years old, and the AML is newly diagnosed (no prior AML treatment except limited options).
  • Your AML has one of these genetic patterns: NPM1-mutated with FLT3-ITD wildtype and/or FLT3-TKD wildtype (dose-expansion arm), or MLL/KMT2A rearranged, or NUP98 alterations.
  • You must be eligible for intensive induction chemotherapy (and can be in dose-escalation or dose-expansion groups).
  • Your general condition is good enough for treatment: ECOG 0–2 (and if you’re over 65, ECOG must be 0–1).
  • Key organ tests must be safe: liver tests not too high, kidney function okay (GFR ≥ 60), and bilirubin within limits (with an exception for Gilbert’s syndrome).
  • Heart and heart-rhythm safety tests must be okay: adequate ejection fraction (≥50%, or ≥45% in certain cases) and QTcF below 450 ms at screening (with some allowed exceptions if cardiology clears you).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT06222580Recruiting· Phase 1
Combination of two targeted drugs for resistant FLT3-mutated AML

This trial tests a combination of two targeted drugs, SNDX-5613 and gilteritinib, for people whose AML has come back or hasn't responded to treatment. It is for those with an FLT3 gene mutation plus another specific genetic change like NPM1 or MLL. The study aims to see if this two-drug approach works better when used together.

Chapel Hill, North Carolina
NCT05360160Recruiting· Phase 1/Phase 2
Oral menin inhibitor plus AML medicines for new or relapsed AML

This trial tests an all-pill (oral) combination treatment—menin inhibitor SNDX-5613 plus decitabine/cedazuridine (ASTX727) and venetoclax—for acute myeloid leukemia (AML). It’s designed for people who are newly diagnosed and can’t get the strongest chemotherapy, or for certain other AML groups who may still benefit.

Houston, Texas
NCT05554406Recruiting· Phase 2
New drug therapy for high-risk AML

This trial is testing new drug combinations for people with newly diagnosed, high-risk AML who have not yet started treatment. It aims to find more effective therapies for this aggressive form of leukemia.

Birmingham, Alabama
NCT07223814Recruiting· Phase 3
Testing a new drug with standard chemo for AML

This trial adds an experimental drug called bleximenib to the usual chemotherapy for people newly diagnosed with AML who have certain genetic changes (NPM1 or KMT2A). The goal is to see if adding this drug helps the treatment work better.

San Francisco, California
NCT06313437Recruiting· Phase 1
Revumenib with 7+3 and midostaurin for AML

This trial tests a new drug called revumenib combined with a strong chemotherapy regimen (7+3) and midostaurin for people with newly diagnosed AML that has specific gene mutations (FLT3 and NPM1). The goal is to see if this combination works better than standard treatments.

New Haven, Connecticut
NCT04293562Recruiting· Phase 3
Testing targeted drugs plus chemo for newly diagnosed AML

This study compares standard chemotherapy to chemotherapy plus CPX-351 and/or gilteritinib in children and young adults newly diagnosed with AML. It aims to see whether adding these targeted treatments improves outcomes, especially for certain gene changes like FLT3.

Birmingham, Alabama

Hear when a new Acute Myeloid Leukemia trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.