drugset / Trial / NCT00871546
SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)
RandomizedParallel-groupOpen-labelTreatment
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 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.
Timeline
- Start
- 2009-03
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alemtuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Comparator | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Dinaciclib | Small molecule | 50 mg/m2 | Intravenous |