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Therapeutic Areas: Oncology
Disease Category: Mantle Cell Lymphoma

Trial Information

A Randomized Phase 2 Study of SCH727965 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL)

This is a randomized, multicenter, open-label study of SCH 727965 and comparator drugs in subjects with relapsed or refractory MCL or CLL. The comparator drug will be bortezomib for subjects with MCL, or alemtuzumab for subjects with CLL. This study is to be conducted in conformance with Good Clinical Practice.

Patient Inclusion Criteria:

• A subject must be 18 years of age or older, of either sex, and of any race.
• For subjects with MCL: a. A subject must have a diagnosis of MCL according to World Health Organization (WHO) criteria. b. A subject must have received at least one prior chemotherapeutic regimen, but no more than three prior regimens including stem cell transplantation. Exception: a subject who experienced disease progression within 6 months of stem cell infusion is not eligible. c. A subject must have measurable or assessable disease by Revised Response Criteria for Malignant Lymphoma. d. A subject must have adequate organ function and laboratory parameters
• For subjects with CLL: a. A subject must have documented B-CLL according to NCI-WG criteria, or histologic diagnosis of small lymphocytic lymphoma. b. A subject must have received at least one prior alkylating agent-based regimen and one fludarabineor pentostatin-containing regimen, but must not have received more than two prior regimens. c. A subject must have measurable or assessable disease by NCI-WG criteria. d. A subject must have adequate organ function and laboratory parameters
• A subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• A subject must be willing to give written informed consent and able to adhere to dose and visit schedules 6. A woman of child-bearing potential or a man and his female sexual partner(s) of child-bearing potential,who are sexually active, must agree to use a medically accepted method to prevent pregnancy.

The subject will be excluded from entry if ANY of the criteria listed below are met:

• Subject with known central nervous system involvement of MCL or CLL.
• Subject who has received any radiation therapy within 4 weeks prior to the start of treatment.
• Subject with a history of second malignancy. Nonmelanoma skin cancer or carcinoma in situ of the cervix treated with curative intent at least 2 years prior to start of treatment or other adequately treated malignancy for which the subject has been disease-free for =2 years is allowed.
• Subject with MCL will be excluded for any of the following: a. previous treatment with bortezomib; b. known hypersensitivity to bortezomib, boron, or mannitol.
• Subject with CLL will be excluded for any of the following: a. previous treatment with alemtuzumab; b. known hypersensitivity to alemtuzumab or its excipients;
• Subject who has received previous treatment with SCH 727965 or other CDK inhibitors.
• Subject with allergy/sensitivity to SCH 727965 or its excipients.
• Subject who has received any treatment listed in the table below more recently than the indicated washout period prior to start of treatment or who must continue to receive treatment with the prohibited medications. Prohibited Medications Washout Period Prior to Start of Treatment Cytochrome P450 3A4 inhibitors or inducers 1 week Any chemotherapy 4 weeks Investigational drugs 4 weeks Radioor toxin immunoconjugates 10 weeks
• Subject without resolution of toxic effects of prior therapy (subjects with residual toxicity of Grade 1 from prior therapy may be considered after discussion with the sponsor).
• Subject with known human immunodeficiency virus.
• Subject with known active hepatitis B or hepatitis C.
• Subject with any serious or uncontrolled infection.
• Woman who is breast-feeding, pregnant, or intends to become pregnant.
• Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
• Subject who is unlikely to complete the study and appropriate follow-up visits.
• Subject who is concurrently receiving treatment in any other clinical study.

Cathy Spears, RN, Manager
St. Francis Hospital and Health Centers
1500 Albany Street, Ste. 1001
Beech Grove, IN 46107
Phone: 317-782-7820
Fax: 317-782-7828
EMail: Cathy.Spears@ssfhs.org

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