Status:
TERMINATED
SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma \[MCL\] or alemtuzumab for B cell chronic lymphocytic leukemia \[B CLL\]). Part 1 of the study w...
Eligibility Criteria
Inclusion
- 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 Lymphoma.
- For subjects with B-CLL
- Documented B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria.
- Received at least one prior alkylating agent-based regimen and one fludarabine- or pentostatin-containing regimen, but must not have received more than two prior regimens.
- Measurable or assessable disease by NCI-WG criteria.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00871546
Start Date
March 1 2009
End Date
December 1 2010
Last Update
August 7 2015
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