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NCT02421939 · ClinicalTrials.gov registry record · Phase 3
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 371
- Enrollment target
NCT02421939 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 371 participants.
The verdict
NCT02421939, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 371 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and determined the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study also determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Interventions
- DRUG Azacitidine
- DRUG gilteritinib
- DRUG LoDAC (Low Dose Cytarabine)
- DRUG MEC (Mitoxantrone, Etoposide, Cytarabine)
- DRUG FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2015-10-20 |
| Est. Completion | 2025-02-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02421939
The ClinicalTrials.gov registry entry for NCT02421939 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 371 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.
NCT02421939 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02421939 about?
NCT02421939 is a clinical study titled "A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation". The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage che...
What is the current status of trial NCT02421939?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2015-10-20. Estimated completion is 2025-02-25.
What interventions are being tested in trial NCT02421939?
The interventions under investigation include: Azacitidine (DRUG), gilteritinib (DRUG), LoDAC (Low Dose Cytarabine) (DRUG), MEC (Mitoxantrone, Etoposide, Cytarabine) (DRUG), FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin) (DRUG).
Who is sponsoring clinical trial NCT02421939?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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