A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
ConditionAML (Acute Myeloid Leukemia)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharm Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CHM-029
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov