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A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia - NCT00866281-98105(Clinical Trial 364341)



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City:  Seattle
State:  
WA
Zip Code: 98105
Conditions: Acute Myeloid Leukemia - Acute Lymphoblastic Leukemia
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - Mixed-lineage leukemia (MLL) gene rearranged Acute Lympoblastic 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
Study is available at: Seattle Children's Hospital
Seattle, WA 98105
United States

Primary Contact:
Sara Muchinsky
Email: Sara.muchinsky@seattlechildrens.org
Phone: 206-884-1591

Secondary Contact:
Novartis Pharmaceuticals
Phone: +1 800 340 6843
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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