QuANTUM-First
Research type
Research Study
Full title
A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM-First)
IRAS ID
202073
Contact name
Christopher Pocock
Contact email
Sponsor organisation
DAIICHI SANKYO, INC.
Eudract number
2015-004856-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 10 days
Research summary
The purpose of this research study is to test how well the study medication, Quizartinib, works when taken with standard chemotherapy to put Newly Diagnosed Acute Myeloid Leukemia (AML) into remission and then taken alone to prevent relapses of AML.
The type of AML being studied in this clinical trial is known as FLT3-ITD positive AML. This type of AML has an alteration (or mutation) in genes, which usually indicates a worse prognosis. Quizartinib works by changing the activity of the FLT3-ITD mutation. Some patients in other studies using Quizartinib had either a complete or a partial remission of their Relapsed/Refractory AML.
Quizartinib has not been approved by Health Authorities to treat patients with AML, and so it is considered an investigational product in this study. The chemotherapy drugs cytarabine, daunorubicin, and idarubicin are all marketed products, approved by the United States Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of AML.
Approximately 536 patients with FLT3-ITD positive AML will participate in the study across approximately 250 medical centres worldwide. The study is divided into 4 phases: induction phase, consolidation phase, maintenance phase and long-term follow-up phase. Patients will receive up to 18 cycles of Quizartinib or Placebo. The duration of patient participation will be until death, withdrawal of consent, lost-to follow-up or study closure. Procedures will include, but are not limited to, blood tests, vital signs, a test to measure heart activity (electrocardiogram), local and central bone marrow assessments, bone marrow aspirates and/or biopsies and answering questions about quality of life.
Daiichi Sankyo, Inc. is funding the research.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/1083
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion