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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: Completed 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
RFS was defined as the time from the date of randomization until the date of documented relapse or death from any cause, whichever occurred first. Relapse after complete remission (CR) \[including complete remission with incomplete platelet recovery (CRp) and Complete remission with incomplete hematologic recovery (CRi)\], was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised Internatio
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 |
What the finished NCT02927262 record still lists
NCT02927262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (31% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT02927262's enrollment target sits among peer trials
98 13th of 29 higher than 17 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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.
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