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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 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 356 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02997202
The ClinicalTrials.gov registry entry for NCT02997202 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 356 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 2 interventions - of which Placebo is the first listed.
NCT02997202 reports 0 study locations.
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.
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