Viewing Study NCT02927262



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Last Modification Date: 2024-10-26 @ 12:11 PM
Study NCT ID: NCT02927262
Status: COMPLETED
Last Update Posted: 2024-03-15
First Post: 2016-10-05

Brief Title: A Study of ASP2215 Gilteritinib Administered as Maintenance Therapy Following InductionConsolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 FLT3ITD Acute Myeloid Leukemia AML in First Complete Remission
Sponsor: Astellas Pharma Global Development Inc
Organization: Astellas Pharma Inc

Study Overview

Official Title: A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib ASP2215 Administered as Maintenance Therapy Following InductionConsolidation Therapy for Subjects With FLT3ITD AML in First Complete Remission
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: True
If Expanded Access, NCT#: NCT03070093
Has Expanded Access, NCT# Status: APPROVED_FOR_MARKETING
Acronym: None
Brief 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 inductionconsolidation chemotherapy for a two-year period
Detailed Description: Participants in CR1 were approached for this study after inductionconsolidation therapy was complete and a decision not to proceed with transplantation was made or a suitable donor could not be identified Participants were randomized in a 21 ratio to receive gilteritinib or placebo Participants entered the screening period up to 14 days prior to the start of treatment Participants were administered treatment over continuous 28-day cycles Gilteritinib or placebo was given daily for up to 2 years After treatment discontinuation participants had a 30-day follow-up visit for safety after which the participants entered the long-term follow up period for collection of subsequent AML treatment remission status and survival cause of death and date of death Final database lock will occur when last subject last follow-up visit is reached per protocol Study drug was not provided during the follow-up period

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2016-001643-39 EUDRACT_NUMBER None None