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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.

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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

FieldValue
Enrollment Target 356 participants
Start Date 2017-08-16
Est. Completion 2023-05-09
Phase Phase 3

Sponsor

Astellas Pharma Global Development

168 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.