deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 5-arm NCT03850574

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

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)

Sponsor: Aptose Biosciences Inc.

Conditions Chronic Myelomonocytic Leukemia Leukemia, Myeloid, Acute Myelodysplastic Syndrome With Excess Blasts-2 Refractory AML Relapsed Adult AML
Interventions Azacitidine for Intravenous Infusion Tuspetinib Venetoclax Oral Tablet
Updated 17 times since 2019 Last updated: Aug 20, 2025 Started: Mar 11, 2019 Primary completion: Nov 30, 2026 Completion: Apr 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03850574, this PHASE1/PHASE2 trial focuses on Chronic Myelomonocytic Leukemia and Leukemia, Myeloid, Acute and remains actively recruiting participants. Sponsored by Aptose Biosciences Inc., it has been updated 17 times since 2019, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Mar 2019 – ~Sep 2020 · 18 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Sep 2023 · 4 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Jan 2025 · 3 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Jan 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Oct 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

▶ Show 12 earlier versions

  1. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  3. Sep 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  4. May 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  5. Feb 2023 — May 2023 [monthly]

    Recruiting PHASE1_PHASE2

  6. Sep 2022 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

  7. Apr 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Sep 2021 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  12. Mar 2019 — Sep 2020 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aptose Biosciences Inc.
Data source: Aptose Biosciences Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albury, Australia , Atlanta, United States , Barcelona, Spain , Berlin, Germany , Birmingham, United States , Boston, United States , Cleveland, United States , Columbus, United States , Daegu, South Korea , Duarte, United States and 21 more locations