A Phase 1/2, Multi-center, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in combination with Re-Induction Chemotherapy, and as a Single-Agent ContinuationTherapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to 18 Years(and Young Adults Aged up to 21 Years) with FLT3-ITD Mutations (Leukemia)
Study of Quizartinib in Combination with Chemotherapy for Children and Young Adults with Recurrent /Refractory Acute Myeloid Leukemia (AML)
Sponsor: Daiichi Sankyo, Inc IN004076
Enrolling: Male and Female Patients
IRB Number: AAAT3164
U.S. Govt. ID: NCT03793478
Contact: Nobuko Hijiya: 212-305-9770 / nh2636@cumc.columbia.edu
Additional Study Information: The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with chemotherapy drugs cytarabine and fludarabine.
This study is closed
Investigator
Luca Szalontay, MD
Do You Qualify?
Are you or your child under the age of 21? Yes No
Have you or your child been diagnosed with recurrent or refractory AML? Yes No
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For more information, please contact:
Nobuko Hijiya
nh2636@cumc.columbia.edu
212-305-9770
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