Campath Maintenance in Chronic Lymphocytic Leukemia

This is a study designed to test whether giving alemtuzumab on a maintenance schedule will prolong the time until the patient requires chemotherapy.

This is an open-label, single arm, proof-of-principle study of alemtuzumab maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.

Inclusion Criteria:

• Enrollment in this study is open to patients 18 years of age with confirmed CLL, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

• Treatment failure in more than 3 prior regimens
• Active secondary malignancy
• Central nervous system involvement with CLL
• History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
• History of HIV positivity
• Hepatitis C virus (HCV) positivity based upon core antigen testing
• Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
• Pregnancy or lactation
• Other severe, concurrent diseases or mental disorders