SCCA Clinical Studies: Phase 1 Program
PF-04449913 w/ Chemotherapy for AML or MDS
A Phase 1B Study To Evaluate The Safety And Preliminary Efficacy Of PF-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-C Or Decitabine In Patients With Acute Myeloid Leukemia Or High Risk Myelodysplastic Syndrome
|Closed||Acute Myeloid Leukemia
High-risk Myelodysplastic Syndrome
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
Eligibility Criteria (must meet the following to participate in this study)
- 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 approved prior targeted therapy (eg, Azacytidine or decitabine) 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
Exclusions (conditions that would prevent participation in this study)
- AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.
- Patients in whom, at the time of study entry, a stem cell transplant is planned within the next 6 months.
- Patients with known active uncontrolled central nervous system (CNS) leukemia.
Last UpdatedJuly 23, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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