SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715AM2)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00871546
First received: March 26, 2009
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: SCH 727965
Drug: Bortezomib
Biological: Alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00871546     History of Changes
Other Study ID Numbers: P04715
Study First Received: March 26, 2009
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Alemtuzumab
Bortezomib
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014