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

Primary Purpose

Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCH 727965
Bortezomib
Alemtuzumab
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Mantle-Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Participants with MCL randomized to SCH 727965

    Participants with MCL randomized to bortezomib

    MCL treated w/SCH 727965 after progression on bortezomib

    Participants with B-CLL randomized to SCH 727965

    Participants with B-CLL randomized to alemtuzumab

    B-CLL treated w/ SCH 727965 after progression on alemtuzumab

    Arm Description

    Outcomes

    Primary Outcome Measures

    Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.
    Response rate in subjects treated with SCH 727965 after disease progression on comparator drug.

    Secondary Outcome Measures

    Time to disease progression for initial treatment with SCH 727965.
    Time to disease progression and response rate for treatment with the comparator drug.
    Response rate for treatment with the comparator drug.
    Time to disease progression in participants treated with SCH 727965 after disease progression on comparator drug.

    Full Information

    First Posted
    March 26, 2009
    Last Updated
    August 6, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00871546
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants with MCL randomized to SCH 727965
    Arm Type
    Experimental
    Arm Title
    Participants with MCL randomized to bortezomib
    Arm Type
    Active Comparator
    Arm Title
    MCL treated w/SCH 727965 after progression on bortezomib
    Arm Type
    Experimental
    Arm Title
    Participants with B-CLL randomized to SCH 727965
    Arm Type
    Experimental
    Arm Title
    Participants with B-CLL randomized to alemtuzumab
    Arm Type
    Active Comparator
    Arm Title
    B-CLL treated w/ SCH 727965 after progression on alemtuzumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SCH 727965
    Intervention Description
    SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.
    Intervention Type
    Drug
    Intervention Name(s)
    Bortezomib
    Other Intervention Name(s)
    Velcade
    Intervention Description
    Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.
    Intervention Type
    Biological
    Intervention Name(s)
    Alemtuzumab
    Other Intervention Name(s)
    Campath
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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)
    Title
    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)
    Secondary Outcome Measure Information:
    Title
    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)
    Title
    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).
    Title
    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).
    Title
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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