Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with MCL randomized to SCH 727965 | Experimental |
| |
| Participants with MCL randomized to bortezomib | Active Comparator |
| |
| MCL treated w/SCH 727965 after progression on bortezomib | Experimental |
| |
| Participants with B-CLL randomized to SCH 727965 | Experimental |
| |
| Participants with B-CLL randomized to alemtuzumab | Active Comparator |
| |
| B-CLL treated w/ SCH 727965 after progression on alemtuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 727965 | Drug | SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL. | 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 to identified disease progression on SCH 727965 in Part 2 (approx. 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression for initial treatment with SCH 727965. | 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 to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL). |
Not provided
Inclusion Criteria:
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:
For subjects with B-CLL
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C553669 | dinaciclib |
| D000069286 | Bortezomib |
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bortezomib | Drug | Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression. |
|
|
| Alemtuzumab | Biological | 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 for treatment with the comparator drug. | 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 to identified disease progression on SCH 727965 in Part 2 (approx. 6 months) |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |