Post-transplant Gilteritinib maintenance in acute myeloid leukaemia
Research type
Research Study
Full title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML
IRAS ID
216307
Contact name
Manoj Satyavarapu
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2016-001061-83
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Acute myeloid leukaemia (known as AML) is a type of blood cancer that develops within the bone marrow. Bone marrow is 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. There is currently no cure for the disease but treatments can cause AML to go into remission. Remission is when there are no signs or symptoms from the disease. Some patients receive a stem-cell transplant after remission to help the bone marrow create more mature white blood cells. Remission may last from months to years, but most people with the disease eventually relapse (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 the drug works and what side effects are seen. With this study, some patients with AML with the FLT3 gene and currently in remission after transplant will be given Gilteritinib. The study is ‘placebo-controlled’ which means some patients will be given a dummy drug to act as a comparison. Gilteritinib should reduce the action of the FLT3 gene leading to longer remission for patients.
This clinical trial is being run in a number of centers 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 Global Pharma Incorporated. Around 346 patients are expected to be involved in the trial.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0152
Date of REC Opinion
4 Jul 2017
REC opinion
Further Information Favourable Opinion