A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML (NCT07751991) | Clinical Trial Compass
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
United States40 participantsStarted 2026-08
Plain-language summary
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.
Who can participate
Age range
18 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:
* 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
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
1
Number of participants with dose limiting toxicities (DLTs)
Timeframe: Baseline through Day 28
2
Number of participants with adverse events (AEs)
Timeframe: Baseline through study completion, an average of 3 years
3
Number of participants with adverse events (AEs) by severity
Timeframe: Baseline through study completion, an average of 3 years
4
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Timeframe: Baseline through study completion, an average of 3 years
5
Rates of dose modification due to adverse events (AEs) according to NCI CTCAE
Timeframe: Baseline through study completion, an average of 3 years
6
Maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of CHM-029
Timeframe: Baseline through study completion, an average of 3 years