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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00871546
• Other study ID #: P04715
• Status: Terminated
• Phase: Phase 2
• First received: March 26, 2009
• Last updated: August 6, 2015
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21-day cycle until disease progression.
• Bortezomib
Bortezomib 1.3 mg/m2 IV on Days 1, 4, 8, and 11 of each 21-day cycle until disease progression.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Time to disease progression for initial treatment with SCH 727965.		Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)	No
Secondary	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).	No
Secondary	Response rate for treatment with the comparator drug.		Time to identified disease progression on comparator drug (bortezomib for MCL or alemtuzumab for B-CLL).	No
Secondary	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)	No