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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Time to Progression (Months)
Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.
Time frame: Every 8 weeks
Rate of Infections
Number of participants who developed clinical or laboratory evidence of infection.
Time frame: Weekly then every 2 weeks then every 3 weeks
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