AML-IDH1
Research type
Research Study
Full title
A Retrospective Chart Review of Adult Patients with R/R IDH1 Mutant Acute Myeloid Leukemia
IRAS ID
257967
Contact name
Mike Storm
Contact email
Sponsor organisation
Agios Pharmaceuticals
Duration of Study in the UK
0 years, 2 months, 29 days
Research summary
This is a retrospective, multi-center, chart-review study of patients with Relapse/Refractory Acute Myeloid Leukemia who have a mutation in IDH1.
The target is to identify approximately 140 patients (male or female) 18 years and older with R/R AML and a confirmed IDH1 mutation. 100 patients in France and approximately 40 patients each in 4 additional European countries (Germany, Italy, Spain, and the UK).
Acute myeloid leukemia (AML) is a heterogeneous group of diseases with a wide array of clinical presentations and outcomes. With the advent of gene sequencing, mutational profiling can enhance risk stratification, prognosis, and treatment decisions. Mutations in isocitrate dehydrogenase-1 (IDH1) are reported in 6-10% of patients with AML. The impact of IDH1 mutations on prognosis, clinical management and costs incurred to the hospital is not well described.
The goal and primary objective of this study is to describe outcomes in patients with relapsed or refractory AML with an IDH1 mutation. The secondary objective is to determine costs associated with IDH1 mutant R/R AML.
The study will last 1 year.REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/0630
Date of REC Opinion
2 May 2019
REC opinion
Favourable Opinion