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RECRUITING Phase 1

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT03850574 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Tuspetinib
  • DRUG Venetoclax Oral Tablet
  • DRUG Azacitidine for Intravenous Infusion

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • University of California Irvine — Irvine
  • UCSD Moores Cancer Center — La Jolla
  • USC/Norris Comprehensive Cancer Center — Los Angeles
  • Stanford Cancer Center — Palo Alto
  • University of California, Davis — Sacramento

Ohio

  • Cleveland Clinic - Taussig Cancer Center — Cleveland
  • The Ohio State University Wexner Medical Center — Columbus

Queensland

  • Royal Brisbane and Women's Hospital — Herston
  • Townsville University Hospital — Townsville

Alabama

  • The Kirklin Clinic of UAB Hospital — Birmingham

Connecticut

  • Yale University — New Haven

Florida

  • University of Miami - Miller School of Medicine — Miami

Georgia

  • Emory University — Atlanta

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2019-03-11
Est. Completion 2027-04
Phase Phase 1

Sponsor

Aptose Biosciences

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03850574

The ClinicalTrials.gov registry entry for NCT03850574 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aptose Biosciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Tuspetinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03850574 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Ohio, Queensland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03850574 about?

NCT03850574 is a clinical study titled "Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia". 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 (CMM...

What is the current status of trial NCT03850574?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2019-03-11. Estimated completion is 2027-04.

What conditions does trial NCT03850574 study?

This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndrome With Excess Blasts-2, Refractory AML, Relapsed Adult AML. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03850574?

The interventions under investigation include: Tuspetinib (DRUG), Venetoclax Oral Tablet (DRUG), Azacitidine for Intravenous Infusion (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03850574?

This trial is sponsored by Aptose Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03850574 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial