Salvage Chemotherapy +/- Crenolanib in relapsed/refractory FLT3+ AML

• Research type

  Research Study

• Full title

  Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

• IRAS ID

  274714

• Contact name

  Vinay Jain

• Contact email

  vjain@arogpharma.com

• Sponsor organisation

  Arog Pharmaceuticals, Inc.

• Eudract number

  2017-001600-29

• Clinicaltrials.gov Identifier

  NCT03250338

• Duration of Study in the UK

  2 years, 2 months, 2 days

• Research summary

  The purpose of this study is to find out if there is added benefit in patients with FLT3 mutant acute myeloid leukemia by adding an investigational drug called crenolanib to standard treatment with Cytarabine and Mitoxantrone (MC) or Fludarabine, Cytarabine, Idarubicin with Granulocyte colony stimulating factor (FLAG-IDA) in patients with leukemia that has relapsed or progressed despite previous treatments. Patients will have a 50/50 chance to recieve crenolanib or placebo in addition to standard chemotherapy.

• REC name

  Wales REC 3

• REC reference

  20/WA/0033

• Date of REC Opinion

  1 Apr 2020

• REC opinion

  Further Information Favourable Opinion