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Complete title: 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 (WIRB 20120285, Study 1132239)
|Research Study Number||2592.00|
|Principal Investigator||Vivian Oehler, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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.
Other exclusion criteria may apply.
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia
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