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NCT02927262 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT02927262 is a Phase 2 study of Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 98 participants, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT02927262, a Phase 2 study of Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2017-01-10 |
| Est. Completion | 2024-02-19 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (31% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
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.
NCT02927262 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Florida, Illinois.
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.
What interventions are being tested in trial NCT02927262?
The interventions under investigation include: Placebo (DRUG), Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT02927262?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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.
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