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 will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug during Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.
Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.
Alemtuzumab dose-titrated to the goal maintenance dose of 30 mg/day IV or SC three times a week on alternate days for a total of 12 weeks.
Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
Time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Response rate in subjects treated with SCH 727965 after disease progression on comparator drug.
Time frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
Time to disease progression for initial treatment with SCH 727965.
Time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Time to disease progression and response rate for treatment with the comparator drug.
Time frame: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
Response rate for treatment with the comparator drug.
Time frame: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
Time to disease progression in participants treated with SCH 727965 after disease progression on comparator drug.
Time frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
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