A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT ID: NCT01546038
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-464
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.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Daniel DeAngelo, MD,
Dana-Farber Cancer Institute
Eyal Attar, MD,
Massachusetts General Hospital
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
- 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
- AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic
- 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.