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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate of initial treatment with SCH 727965 in subjects with MCL or B-CLL.

Outcome Time Frame:

Time to identified disease progression on SCH 727965 in Part 1 (approx. 6 months)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P04715

NCT ID:

NCT00871546

Start Date:

March 2009

Completion Date:

December 2010

Related Keywords:

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

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