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

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ClinicalTrials.gov Identifier: NCT00871546
Recruitment Status : Terminated
First Posted : March 30, 2009
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Mantle-Cell Leukemia, Lymphocytic, Chronic, B-Cell Drug: SCH 727965 Drug: Bortezomib Biological: Alemtuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010


Arm Intervention/treatment
Experimental: Participants with MCL randomized to SCH 727965 Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.

Active Comparator: Participants with MCL randomized to bortezomib Drug: Bortezomib
Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.
Other Name: Velcade

Experimental: MCL treated w/SCH 727965 after progression on bortezomib Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.

Experimental: Participants with B-CLL randomized to SCH 727965 Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.

Active Comparator: Participants with B-CLL randomized to alemtuzumab Biological: Alemtuzumab
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.
Other Name: Campath

Experimental: B-CLL treated w/ SCH 727965 after progression on alemtuzumab Drug: SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.




Primary Outcome Measures :
  1. 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) ]
  2. 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 Measures :
  1. 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) ]
  2. 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). ]
  3. 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). ]
  4. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00871546     History of Changes
Other Study ID Numbers: P04715
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Bortezomib
Alemtuzumab
Antineoplastic Agents
Antineoplastic Agents, Immunological