Campath Maintenance in Chronic Lymphocytic Leukemia
Campath Maintenance in Chronic Lymphocytic Leukemia
This is a study designed to test whether giving campath (also known as 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 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