Clinical trial NCT00871546: SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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:

  * 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 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.

Primary outcomes:
measure: Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
timeFrame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
measure: Response rate in subjects treated with SCH 727965 after disease progression on comparator drug.
timeFrame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
Secondary outcomes:
measure: Time to disease progression for initial treatment with SCH 727965.
timeFrame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
measure: Time to disease progression and response rate for treatment with the comparator drug.
timeFrame: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
measure: Response rate for treatment with the comparator drug.
timeFrame: Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).
measure: Time to disease progression in participants treated with SCH 727965 after disease progression on comparator drug.
timeFrame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 6 months)
Other outcomes:
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Study officials:
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