A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
Inclusion Criteria:
- For participants with AML:
- Age >=60 years, either sex, any race.
- Diagnosis of CD33-positive AML by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory
disease at first salvage, and not be considered a candidate for transplant.
- Acute promyelocytic leukemia who has relapsed following treatment with both all
trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
- For participants with ALL:
- Age >=18 years, either sex, any race.
- Diagnosis of ALL by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory
disease at first salvage, and not be considered a candidate for potentially
curative therapy.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory
parameters.
- 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.