QuANTUM-Wild
Research type
Research Study
Full title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy And Administered as Maintenance Therapy in Adult Patients with Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia (QuANTUM-Wild)
IRAS ID
1010769
Contact name
Bettina Steffens
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Clinicaltrials.gov Identifier
Research summary
This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients (between 18 and 70 years old) with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukaemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
The study will be conducted at approximately 260 hospitals in North America, Europe, the United Kingdom, Asia, and South America and will enrol approximately 700 patients.
Participants will be randomly (like flipping a coin) assigned in a 2:2:1 ratio into 3 treatment arms:
• Arm A will receive quizartinib for the whole study (together with chemotherapy in induction and consolidation, then quizartinib alone in maintenance). There will be about 280 patients in this group.
• Arm B will receive placebo through the whole study (together with chemotherapy in induction and consolidation, then placebo alone in maintenance). There will be about 280 patients in this group.
• Arm C will receive quizartinib during the induction and consolidation period with chemotherapy, then placebo alone during the maintenance period. There will be about 140 patients in this group.The trial is expected to last approximately 5 years with a maximum duration of study treatment of 52 months and consists of 5 phases (Screening, Induction, Consolidation, Maintenance, and Long-term Follow-up). Patients will have a follow-up visit 30 days after stopping the study drug and then additional follow-up visit(s) every 4 or 12 weeks, depending on the status of their disease, until the end of the trial.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0260
Date of REC Opinion
30 Jan 2025
REC opinion
Further Information Favourable Opinion