A Randomized Phase 2 Study of SCH 727965 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL)
- Age >=18 years, either sex, any race.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- For subjects with MCL:
- Diagnosis of MCL according to the World Health Organization (WHO) criteria.
- Received at least one prior chemotherapeutic regimen, but no more than two
regimens including stem cell transplantation..
- Measurable or assessable disease by the Revised Response Criteria for Malignant
- For subjects with B-CLL
- Documented B-CLL according to the National Cancer Institute Working Group
- Received at least one prior alkylating agent-based regimen and one fludarabine-
or pentostatin-containing regimen, but must not have received more than two
- Measurable or assessable disease by NCI-WG criteria.
- Known central nervous system involvement of MCL or B-CLL.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For MCL, previous treatment with bortezomib.
- For B-CLL, previous treatment with alemtuzumab.
- Known HIV infection.
- Known active hepatitis B or C.