Gilteritinib as Maintenance After Induction/Consolidation in CR1 AML
Research type
Research Study
Full title
A Phase 3 Multicentre, Randomised, 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
IRAS ID
213979
Contact name
Sirjana Gurung
Contact email
Sponsor organisation
Astellas Global Pharma Inc.
Eudract number
2016-001643-39
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Acute myeloid leukaemia (known as AML) is a type of blood cancer that develops within the bone marrow (the spongy inner part of bones where new cells are made). When untreated, there are not enough mature white blood cells. As mature white blood cells are the active part of the immune system, this leaves people with AML vulnerable to infection. People with AML also get swollen internal organs (such as the spleen) as the cells build up.
There is currently no effective cure but treatments can cause AML to enter remission. Remission is when there are no signs or symptoms of disease. Remission may last from months to years but most people will eventually relapse (this means the disease returns).
Relapse often happens sooner in people with AML who have a specific gene activated within their bone marrow. This gene is called FLT3.
This study is testing an FLT3 inhibitor called Gilteritinib. ‘Inhibitor’ means that it blocks the action of the gene.
The developers of Gilteritinib want to see how well it works and what side effects are seen. With this study, patients with AML that involves the FLT3 gene and are in remission will be given Gilteritinib. The study is ‘placebo-controlled’ which means some patients will be given a dummy drug (which contains no active drug) as a comparison. Gilteritinib has potential to reduce the action of the FLT3 gene in leukaemia cells that might be remaining after chemotherapy and prevent them from growing back. This might lead to longer remission for patients.
This study is taking place in the UK as well as elsewhere in Europe, the USA, Canada, and the rest of the world. The Sponsor of the study is Astellas Pharma Global Development, Inc. Initially, around 555 patients are expected to be involved in the trial.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0063
Date of REC Opinion
24 Apr 2017
REC opinion
Further Information Favourable Opinion