Acute Myeloid Leukemia Clinical Trial
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
Summary
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.
Eligibility Criteria
Inclusion Criteria:
Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed from 2 prior treatments
Normal organ function, and chest x-ray
Expected survival greater than 8 weeks
Can care for most of personal needs and perform at least minimum activity
Exclusion Criteria:
Patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia
Patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants
Patients with heart function that is not normal
Patients with HIV or hepatitis
Patients with another severe disease or medical condition besides leukemia Other protocol-defined inclusion/exclusion criteria may apply
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There are 8 Locations for this study
Seattle Washington, 98105, United States
Paris Cedex 19 , 75935, France
Genova GE, 16147, Italy
Monza MB, 20900, Italy
Roma RM, 00165, Italy
Torino TO, 10126, Italy
Rotterdam , 3015 , Netherlands
Stockholm , SE-17, Sweden
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