A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 89 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Mar 31, 2027 to Jul 29, 2026
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 20 of 24 entries
  2. Re-verified, no change to tracked fieldsv88
  3. Study completion pushed from Mar 31, 2026 to Mar 31, 2027v87
  4. 6 versions Re-verified since Feb 27, 2025, no change to tracked fieldsv81-v86
  5. Results first posted: Jan 14, 2025
    • Secondary endpoints: 21 to 24
    v80
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  1. Start date: Jan 15, 2018 to Oct 25, 2017
    • Interventions: FLAG (Granulocyte colony-stimulating factor (G-CSF), Fludarabine, Cytarabine) (Drug), LoDAC (Low Dose Cytarabine) (Drug), MEC… to Cytarabine (Drug), Etoposide (Drug), Fludarabine (Drug), G-CSF (Drug), Gilteritinib (Drug), Mitoxantrone (Drug)
    • Eligibility criteria revised
    • Study arms: 3 to 2
    v79
  2. 7 versions Re-verified since Feb 22, 2024, no change to tracked fieldsv72-v78
  3. Primary completion date changed from estimate of Feb 29, 2024 to Dec 25, 2023v71
  4. Study sites: 48 to 49v70
  5. Study sites: 47 to 48v69
  6. Study sites: 48 to 47v68
  7. Re-verified, no change to tracked fieldsv67
  8. Primary completion date: Nov 30, 2025 to Feb 29, 2024
    • Study completion date: Nov 30, 2025 to Mar 31, 2026
    v66
  9. 6 versions Re-verified since Dec 12, 2022, no change to tracked fieldsv60-v65
  10. Primary and study completion dates: Oct 31, 2022 to Nov 30, 2025v59
  11. 3 versions Re-verified since Aug 17, 2022, no change to tracked fieldsv56-v58
  12. Primary completion date: Jul 31, 2022 to Oct 31, 2022v55
  13. 15 versions Re-verified since Jun 16, 2021, no change to tracked fieldsv40-v54
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Trial Details
NCT Number NCT03182244
Lead Sponsor Astellas Pharma Inc
Conditions
(from sponsor)		 AML With FLT3 Mutation
Related terms Leukemia, Myeloid, Acute
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov