Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT02421939 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 371 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive. The last contact date was derived for participants alive at the analysis cutoff date. Survi
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 |
What the finished NCT02421939 record still lists
NCT02421939 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.
NCT02421939 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02421939's enrollment target sits among peer trials
371 992nd of 2000 higher than 1,008 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05743673 · 371 participants
SHAPE Test for Preoperative Risk Stratification
- NCT05761847 · 371 participants · NA
Pediatric Medication Therapy Management Trial
- NCT04801589 · 372 participants · Phase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
- NCT04879329 · 372 participants · Phase 2
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI