Campath Maintenance in Chronic Lymphocytic Leukemia

This is an open-label, single arm, proof-of-principle study of Campath (also known as
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 chronic
lymphocytic leukemia, 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