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SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717) - NCT00798213-54601(Clinical Trial 255163)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Leukemia, Myeloid, Acute - Lymphoblastic Leukemia, Acute
Purpose: The study will determine the activity of SCH 727965 treatment in patients with acute myelogenous leukemia (AML) and patients with acute lymphoblastic leukemia (ALL). The study will also determine the activity of SCH 727965 treatment in patients with AML who experience disease progression after standard treatment with gemtuzumab ozogamicin.
Study summary:
Criteria: Inclusion Criteria: - Age >=60 years, either sex, any race. - Diagnosis of either ALL or CD33-positive AML by World Health Organization criteria. - For subjects with AML: - Subject must be in first or second relapse, or have refractory disease, and not be considered a candidate for transplant. - Subject with acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible. - Subject with ALL must be in first or second relapse, or have refractory disease, and not be considered a candidate for potentially curative therapy. - Eastern Cooperative Oncology group performance status of 0, 1, or 2. - Adequate hematologic, renal, and hepatic organ function and laboratory parameters. - Subject receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug. Exclusion Criteria: - Known central nervous system leukemia. - Previous hematopoietic stem cell transplantation. - Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors. - For AML, previous treatment with gemtuzumab ozogamicin. - Known HIV infection. - Known active hepatitis B or C.
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: January 20, 2010
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