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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with MCL randomized to SCH 727965

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Participants with MCL randomized to bortezomib

Group Type ACTIVE_COMPARATOR

Bortezomib

Intervention Type DRUG

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

MCL treated w/SCH 727965 after progression on bortezomib

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Participants with B-CLL randomized to SCH 727965

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Participants with B-CLL randomized to alemtuzumab

Group Type ACTIVE_COMPARATOR

Alemtuzumab

Intervention Type 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.

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

Group Type EXPERIMENTAL

SCH 727965

Intervention Type DRUG

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

Interventions

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SCH 727965

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

Intervention Type DRUG

Bortezomib

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

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Velcade Campath

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No