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
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|ClinicalTrials.gov Identifier: NCT02927262|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation||Drug: gilteritinib Drug: Placebo||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission|
|Actual Study Start Date :||January 10, 2017|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
Subjects will be treated with ASP2215 once daily (continuously for up to 2 years).
Tablet to be taken orally once daily.
Other Name: ASP2215
Placebo Comparator: Placebo
Subjects will be treated with matching placebo tablets once daily (continuously for up to 2 years).
Matching placebo tablet to be taken orally once daily.
- Relapse-free Survival (RFS) [ Time Frame: Up to 61 months ]RFS is defined as the time from the date of randomization until the date of documented relapse or death from any cause, whichever occurs first. Relapse after Complete Remission (CR) (including Complete Remission with incomplete Platelet recovery (CRp) and Complete Remission with incomplete hematologic recovery (CRi)), is 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 International Working Group (IWG) criteria. Relapse events will be adjudicated by an independent review committee and will be used in the efficacy assessments, unless specifically stated otherwise.
- Overall Survival (OS) [ Time Frame: Up to 61 months ]OS is defined as the time from the date of randomization until the date of death from any cause. For surviving subjects, non-events will be censored at the date of last known date alive.
- Event-free survival (EFS) [ Time Frame: Up to 61 months ]EFS is defined as the time from the date of randomization until the date of documented relapse or discontinuation of the treatment, or initiation of other anti-leukemic treatment or death from any cause, whichever occurs first.
- Minimal Residual Disease (MRD) [ Time Frame: Up to 61 months ]MRD will be measured from bone marrow samples. FLT3/ITD mutation ratio will be measured in relation to total FLT3. Changes in FLT3/ITD mutation ratio will be compared with baseline/screening samples.
- Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 61 months ]
- Number of participants with abnormal laboratory values and/or adverse events related to treatment [ Time Frame: Up to 61 months ]
- Number of participants with abnormal vital signs and/or adverse events related to treatment [ Time Frame: Up to 61 months ]
- Safety assessed by electrocardiograms (ECGs) [ Time Frame: Up to 61 months ]The 12-lead ECGs will be recorded in triplicate (3 separate ECGs, 10 minutes resting prior to first ECG and at least 5 minutes apart per time point) and transmitted electronically for central reading. The mean of the triplicate ECG from central read should be used for all final treatment decisions and AE reporting.
- Number of participants with physical exam abnormalities and/or adverse events related to treatment [ Time Frame: Up to 61 months ]
- Eastern Cooperative Oncology Group (ECOG) performance status score [ Time Frame: Up to 24 months ]ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2= Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927262
|Contact: Astellas Pharma Global Developmentfirstname.lastname@example.org|
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|Study Director:||Executive Medical Director||Astellas Pharma Global Development, Inc.|