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NCT02997202 · ClinicalTrials.gov registry record · Phase 3
A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
NCT02997202: Completed Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT02997202 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 356 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02997202, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
Study Summary
The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
Primary Outcome
RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events: * BM blasts ≥ 5% (not attributable to regenerating BM) * Any circulating blasts (not attributable to regenerating BM or growth factors) * Presence of extramedullary blast foci per Revised International Working Group (RIWG) criteria * The earliest date of
Interventions
- DRUG Placebo
- DRUG gilteritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2023-05-09 |
| Phase | Phase 3 |
What the finished NCT02997202 record still lists
NCT02997202 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02997202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02997202 about?
NCT02997202 is a clinical study titled "A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)". The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment fo...
What is the current status of trial NCT02997202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2017-08-16. Estimated completion is 2023-05-09.
What interventions are being tested in trial NCT02997202?
The interventions under investigation include: Placebo (DRUG), gilteritinib (DRUG).
Who is sponsoring clinical trial NCT02997202?
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 NCT02997202's enrollment target sits among peer trials
356 1024th of 2000 higher than 976 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
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