Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Recruiting now · Phase 1/Phase 2
Conditions studied: Leukemia, Myeloid, Acute, Refractory AML, Relapsed Adult AML, Myelodysplastic Syndrome With Excess Blasts-2, Chronic Myelomonocytic Leukemia
In brief
The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.
Key facts
- Study ID
- NCT03850574
- Run by
- Aptose Biosciences Inc.
- People needed
- 240
- Starts
- 2019-03-11
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-08-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California, Davis — Sacramento, California, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- University of Miami - Miller School of Medicine — Miami, Florida, United States (enrolling)
- University of California Irvine — Irvine, California, United States (enrolling)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Stanford Cancer Center — Palo Alto, California, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- MD Anderson Cancer Center — Huston, Texas, United States (enrolling)
- The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States (enrolling)
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- Universitätsklinikum Leipzig — Leipzig, Saxony, Germany
- Charité Universitätsmedizin Berlin — Berlin, State of Berlin, Germany
- Auckland City Hospital — Grafton, Auckland, New Zealand
- Seoul National University Hospital — Seoul, Seoul, South Korea
- Asan Medical Center — Seoul, Seoul, South Korea
- Samsung Medical Center — Seoul, Seoul, South Korea
- Kyungpook National University Hospital — Daegu, South Korea
- Pusan National University Hospital — Pusan, South Korea
- Seoul National University Bundang Hospital — Seongnam, South Korea
- Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain
- Hospital Quirón Madrid — Pozuelo de Alarcón, Madrid, Spain
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain
- Hospital Clinico Universitario de Valencia — Valencia, Valencia, Spain
- Hospital Universitari i Politècnic La Fe — Valencia, Valencia, Spain
Full record on ClinicalTrials.gov
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