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A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML

RecruitingPhase 1Ages 18 Years - anyAllCharm Therapeutics
NCT07751991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to evaluate the safety of CHM-029, an investigational oral medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults. The main questions the study aims to answer are: * What is an appropriate dose of CHM-029? * What side effects may occur with CHM-029? * How does the body process CHM-029? Researchers will evaluate increasing dose levels of CHM-029 to better understand its safety and how the body responds to treatment. Participants will visit the study clinic regularly for safety assessments, blood tests, electrocardiograms (ECGs), and bone marrow evaluations to monitor their health and response to treatment.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years old and above * Relapsed or refractory (R/R) acute myeloid leukemia (AML) and has had treatment with any available standard therapies * Positive for NPM1 mutation, or KMT2A or NUP98 rearrangements Exclusion Criteria: * White blood cell (WBC) count higher than 25,000 u/L that cannot be maintained below threshold with hydroxyurea treatment * Extramedullary only AML * Has current complications related to hematopoietic stem cell transplant (HSCT) * Other cancers that require treatment * Active Hepatitis or HIV infection * Moderate hepatic or renal impairment * Acute promyelocytic leukemia * Baseline prolongation of QT/QTc interval (≥ 470 ms) or additional risk factors for Torsades de Pointes (TdP) * Congestive heart failure NYHA Class 3 or 4 * Central nervous system involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation
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What it tests

  • CHM-029
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Where

5 sites
City of Hope Center Medical Center
Duarte, United States
Yale - New Haven Hospital / Cancer Center
New Haven, United States
START Midwest
Grand Rapids, United States
The Christie NHS Foundation Trust
Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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