deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04240002

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Sponsor: Astellas Pharma Global Development, Inc.

Conditions Acute Myeloid Leukemia (AML) Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
Interventions cytarabine fludarabine gilteritinib granulocyte colony-stimulating factor (G-CSF)
Updated 52 times since 2020 Last updated: Dec 12, 2025 Started: Sep 4, 2020 Primary completion: Mar 11, 2025 Completion: Mar 17, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated due to enrollment challenges.

Other terminated trials from Astellas Pharma Global Development, Inc.

More terminations from Astellas Pharma Global Development, Inc.

Other Acute Myeloid Leukemia (AML) trials with similar outcome

Browse all Acute Myeloid Leukemia (AML) trials

This PHASE1/PHASE2 trial investigates Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD) and is currently terminated or withdrawn. Astellas Pharma Global Development, Inc. leads this study, which shows 52 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Jun 2020 · 2 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Feb 2026 · 8 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

52 versions recorded

  1. Feb 2026 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Jun 2025 — Feb 2026 [monthly]

    Terminated PHASE1/PHASE2

  3. May 2025 — Jun 2025 [monthly]

    Terminated PHASE1/PHASE2

    Status: Recruiting → Terminated

  4. Mar 2025 — May 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Feb 2025 — Mar 2025 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 47 earlier versions

  1. Jan 2025 — Feb 2025 [monthly]

    Recruiting PHASE1/PHASE2

  2. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE1/PHASE2

  4. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE1/PHASE2

  5. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE1/PHASE2

  6. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

  7. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  8. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  9. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE1_PHASE2

  10. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE1_PHASE2

  11. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  13. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  14. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  15. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  16. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  17. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1_PHASE2

  18. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

  19. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

  20. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE1_PHASE2

  21. Feb 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  22. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

  23. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

  24. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1_PHASE2

  25. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  26. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  27. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  28. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  29. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  30. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE1_PHASE2

  31. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  32. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE1_PHASE2

  33. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1_PHASE2

  34. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

  35. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  36. Mar 2021 — May 2021 [monthly]

    Recruiting PHASE1_PHASE2

  37. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  38. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1_PHASE2

  39. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  40. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1_PHASE2

  41. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1_PHASE2

  42. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not Recruiting → Recruiting

  43. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  44. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  45. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  46. Apr 2020 — Jun 2020 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  47. Feb 2020 — Apr 2020 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Global Development, Inc.
Data source: Astellas Pharma Inc

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

Study Locations