SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)

Phase 2

Terminated

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell
• Interventions: Drug: SCH 727965; Biological: Alemtuzumab; Drug: Bortezomib

• Registration Number: NCT00871546
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-30
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with MCL randomized to SCH 727965	SCH 727965	-
MCL treated w/SCH 727965 after progression on bortezomib	SCH 727965	-
Participants with B-CLL randomized to alemtuzumab	Alemtuzumab	-
Participants with B-CLL randomized to SCH 727965	SCH 727965	-
B-CLL treated w/ SCH 727965 after progression on alemtuzumab	SCH 727965	-
Participants with MCL randomized to bortezomib	Bortezomib	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)
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).
Time to disease progression for initial treatment with SCH 727965.	Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)
Response rate for treatment with the comparator drug.	Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).