west CLINICAL TRIALS

Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

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Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

          A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
        

Est. Enrollment: 510 participants

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The number of participants in a clinical study. The "estimated" enrollment is the target number of participants the researchers need for the study.

Study Start Date: Aug 15, 2018

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These are the dates the researchers think the study will start and end.

Study Completion Date: Nov 01, 2024

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The "estimated" study completion date is the date the researchers think the last participant in a clinical study was examined or received an intervention/treatment. This is also the expected date that the study will be completed

Age: 18 to 60 years

Gender: All

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