A Study of Gilteritinib in Acute Myeloid Leukaemia with FLT3 Mutation
Research type
Research Study
Full title
A Phase 2/3 Multicentre, Open-label, 3-arm, 2-stage Randomised Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukaemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy.
IRAS ID
203823
Contact name
Matthew Smith
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2015-001790-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117,548, IND Number
Duration of Study in the UK
3 years, 1 months, days
Research summary
Acute myeloid leukaemia (AML) accounts for 32% of all leukaemia cases. AML is more common in older adults. The median age of diagnosis is 67 years of age, with 54% of patients diagnosed at 65 years and over. Currently, there is no effective cure for this disease.
ASP2215 is an experimental drug that is being studied to treat AML. The aim of the study is to see if ASP2215 given alone or in combination with azacitidine (another type of medicine) is both effective and safe as a treatment for AML patients with mutations in the FLT3 gene compared to azacitidine given alone. Some AML patients have a mutation in the gene called FLT3. When patients have a FLT3 mutation, more of the FLT3 protein made by FLT3 gene is on the leukemic cells, or the protein is more active. This may make the leukemic cells grow faster or live longer. ASP2215 is designed to slow down the growth of leukemic cells by blocking FLT3 protein on those cells. Approximately 528 participants will be randomised in a 1:1:1 ratio to receive ASP2215 (Arm A), ASP2215 plus azacitidine (Arm AC) or azacitidine only (Arm C). The trial will be conducted at approximately 136 centres in North America, Europe and Asia-Pacific. This research study is organised and funded by Astellas Pharma Global Development.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0175
Date of REC Opinion
1 Aug 2016
REC opinion
Further Information Favourable Opinion