Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT03850574. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03850574
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Interventions
- Tuspetinib Drug
- Venetoclax Oral Tablet Drug
- Azacitidine for Intravenous Infusion Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 10, 2019
- Primary completion
- Oct 31, 2026
- Completion
- Mar 31, 2027
- Last update posted
- Aug 25, 2025
2019 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Kirklin Clinic of UAB Hospital | Birmingham | Alabama | 35233 | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Active, not recruiting |
| University of California Irvine | Irvine | California | 92697 | Recruiting |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | Active, not recruiting |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Stanford Cancer Center | Palo Alto | California | 94304 | Recruiting |
| University of California, Davis | Sacramento | California | 95817 | Recruiting |
| Yale University | New Haven | Connecticut | 06520 | Recruiting |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | Recruiting |
| Emory University | Atlanta | Georgia | 30322 | Active, not recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Active, not recruiting |
| Duke University Medical Center | Durham | North Carolina | 27705 | Recruiting |
| Cleveland Clinic - Taussig Cancer Center | Cleveland | Ohio | 44106 | Active, not recruiting |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | Recruiting |
| MD Anderson Cancer Center | Huston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03850574, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2025 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03850574 live on ClinicalTrials.gov.