Testing a menin drug with standard chemo for newly diagnosed AML
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.
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).
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.
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.
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.
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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.
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