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

NCT00871546 | Terminated Phase 2

• 1 other identifier: P04715
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to disease progression for initial treatment with SCH 727965.

  Time to identified disease progression on SCH 727965 in Part 1 (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).

• 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 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)

Study Arms (6)

Participants with MCL randomized to SCH 727965

EXPERIMENTAL

Drug: SCH 727965

Participants with MCL randomized to bortezomib

ACTIVE COMPARATOR

Drug: Bortezomib

MCL treated w/SCH 727965 after progression on bortezomib

EXPERIMENTAL

Drug: SCH 727965

Participants with B-CLL randomized to SCH 727965

EXPERIMENTAL

Drug: SCH 727965

Participants with B-CLL randomized to alemtuzumab

ACTIVE COMPARATOR

Biological: Alemtuzumab

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

EXPERIMENTAL

Drug: SCH 727965

Interventions

SCH 727965 DRUG

SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.

B-CLL treated w/ SCH 727965 after progression on alemtuzumab; MCL treated w/SCH 727965 after progression on bortezomib; Participants with B-CLL randomized to SCH 727965; Participants with MCL randomized to SCH 727965

Bortezomib DRUG

Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.

Also known as: Velcade

Participants with MCL randomized to bortezomib

Alemtuzumab BIOLOGICAL

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.

Also known as: Campath

Participants with B-CLL randomized to alemtuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

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

Interventions

dinaciclib; Bortezomib; Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 7, 2015

Record last verified: 2015-08