Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
Official Title
A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Quick Facts
Study Start:2019-03-11
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
University of California Irvine
Irvine, California, 92697
United States
UCSD Moores Cancer Center
La Jolla, California, 92093
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Stanford Cancer Center
Palo Alto, California, 94304
United States
University of California, Davis
Sacramento, California, 95817
United States
Yale University
New Haven, Connecticut, 06520
United States
University of Miami - Miller School of Medicine
Miami, Florida, 33136
United States
Emory University
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, 44106
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Collaborators and Investigators
Sponsor: Aptose Biosciences Inc.
- Naval Daver, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2019-03-11
Study Completion Date2026-12
Study Record Updates
Study Start Date2019-03-11
Study Completion Date2026-12
Terms related to this study
Keywords Provided by Researchers
- Tuspetinib
- Acute Myeloid Leukemia
- AML
- Relapsed
- Refractory
- Myelodysplastic Syndromes with Increased Blasts Grade 2
- MDS-IB2
- Chronic Myelomonocytic Leukemia
- CMML
- Venetoclax
- Azacitidine
- Newly Diagnosed
Additional Relevant MeSH Terms
- Leukemia, Myeloid, Acute
- Refractory AML
- Relapsed Adult AML
- Myelodysplastic Syndrome With Excess Blasts-2
- Chronic Myelomonocytic Leukemia