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This study evaluates the drug PF-04449913 combined with chemotherapy in patients with Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). It included newly diagnosed patients confirmed by the WHO 2008 classification. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated. * Patients with AML (arising from an antecedent hematologic disease \[AHD\]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML. * AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML) * For a diagnosis of AML, a bone marrow blast count of 20% or more is required. * For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts * Adequate Organ Function * ECOG Performance Status 0, 1, or 2 Exclusion Criteria: * AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation. * Patients with known active uncontrolled central nervous system (CNS) leukemia.