Actively Recruiting
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Led by Aptose Biosciences Inc. · Updated on 2025-08-26
240
Participants Needed
34
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary or secondary AML, MDS-IB2 (≥10% bone marrow blasts), or CMML by WHO 2016 criteria
- Relapsed or refractory after at least one prior therapy, or newly diagnosed AML patients ineligible for intensive chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Suitable for oral administration of study drug with minimum life expectancy of 3 months
- Meet laboratory criteria: AST and ALT ≤3× institutional upper limit normal (ULN); total bilirubin ≤1.5× ULN (or ≤3× ULN for some newly diagnosed patients); creatinine clearance >45 mL/min (relapsed/refractory) or ≥30 mL/min (newly diagnosed)
- Female participants must be non-childbearing or use effective contraception with negative pregnancy test if of childbearing potential
- Male participants and female partners of childbearing potential must use highly effective contraception
- Agree not to participate in another interventional study during treatment
You will not qualify if you...
- Diagnosed with acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia
- Active malignancy other than AML, MDS-IB2, or CMML
- Persistent non-hematological toxicities ≥ Grade 2 from prior treatment
- Recent hematopoietic stem cell transplant (HSCT) within 2 months or active graft-versus-host disease
- Meningeal or central nervous system involvement by leukemia
- Disseminated intravascular coagulation abnormality
- Major surgery or radiation therapy within 4 weeks prior to study drug
- Congestive heart failure NYHA class 3 or 4 or significant cardiac abnormalities
- Known active infection including COVID-19, HIV, active hepatitis B or C
- Significant uncontrolled systemic infection or other medical conditions deemed unsuitable by investigator
- History of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitors
- White blood cell count > 25 x 10^9/L (hydroxyurea or leukapheresis allowed to meet criterion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
3
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
4
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Active, Not Recruiting
5
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
6
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
7
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
8
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
9
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
10
Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
11
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
12
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
13
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
14
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
15
MD Anderson Cancer Center
Huston, Texas, United States, 77030
Actively Recruiting
16
Border Medical Oncology
Albury, New South Wales, Australia, 2640
Active, Not Recruiting
17
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4006
Active, Not Recruiting
18
Townsville University Hospital
Townsville, Queensland, Australia, 4812
Active, Not Recruiting
19
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Active, Not Recruiting
20
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Active, Not Recruiting
21
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Active, Not Recruiting
22
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 13353
Active, Not Recruiting
23
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Active, Not Recruiting
24
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Completed
25
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Active, Not Recruiting
26
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Active, Not Recruiting
27
Kyungpook National University Hospital
Daegu, South Korea, 41944
Active, Not Recruiting
28
Pusan National University Hospital
Pusan, South Korea, 49241
Active, Not Recruiting
29
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Active, Not Recruiting
30
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Active, Not Recruiting
31
Hospital Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Active, Not Recruiting
32
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Active, Not Recruiting
33
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain, 46010
Active, Not Recruiting
34
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain, 46026
Active, Not Recruiting
Research Team
R
Rafael Bejar, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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