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COMPLETED Phase 2

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

NCT02927262 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

Interventions

  • DRUG Placebo
  • DRUG Gilteritinib

Study Locations (20)

Other

  • Site CZ42001 — Ostrava-Poruba
  • Site FR33001 — Bayonne
  • Site FR33009 — Mulhouse
  • Site FR33008 — Nice
  • Site DE49008 — Stuttgart

Florida

  • Site US10017 — Gainesville
  • Site US10030 — Jacksonville

Illinois

  • Site US10012 — Chicago

New York

  • Site US10025 — Syracuse

Oregon

  • Site US10007 — Portland

South Carolina

  • Site US10029 — Greenville

Goiás

  • Site BR55002 — Goiânia

Nova Scotia

  • Site CA15001 — Halifax

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2017-01-10
Est. Completion 2024-02-19
Phase Phase 2

Sponsor

Astellas Pharma Global Development

172 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02927262

The ClinicalTrials.gov registry entry for NCT02927262 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 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 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02927262 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02927262 about?

NCT02927262 is a clinical study titled "A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission". The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning aft...

What is the current status of trial NCT02927262?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2017-01-10. Estimated completion is 2024-02-19.

What conditions does trial NCT02927262 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02927262?

The interventions under investigation include: Placebo (DRUG), Gilteritinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02927262?

This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02927262 being conducted?

This trial has 20 study locations across Florida, Illinois, New York, Oregon, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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