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Phase III, double-blind, randomized, placebo-controlled clinical trial of quizartinib administered in combination with induction and consolidation chemotherapy and as maintenance therapy in adult patients with a diagnosis of
THE PURPOSE OF THIS TRIAL IS TO LEARN MORE ABOUT AN INVESTIGATIONAL DRUG CALLED QUIZARTINIB. AN INVESTIGATIONAL DRUG IS A DRUG THAT IS NOT APPROVED TO TREAT YOUR DISEASE. IT IS BEING STUDIED TO SEE IF YOUR DISEASE OR MEDICAL CONDITION IMPROVES WHILE YOU ARE RECEIVING IT AND IF IT IS SAFE FOR PEOPLE WHO HAVE THE SAME DISEASE AS YOU.
Technical Summary
- PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-COMPARATIVE TRIAL OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY, AND AS MAINTENANCE THERAPY, IN ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA WITHOUT DIT MUTATION IN FLT3 (QUANTUM WILD).
- Code EudraCT: 2023-507936-20-00
- Protocol number: AC220-168
- Promoter: Daiichi Sankyo Inc
- Molecule/Drug: QUIZARTINIB
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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