Spots Global Cancer Trial Database for Campath Maintenance in Chronic Lymphocytic Leukemia

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Trial Identification

Brief Title: Campath Maintenance in Chronic Lymphocytic Leukemia

Official Title: Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia

Study ID: NCT00587847

Conditions

Chronic Lymphocytic Leukemia

Interventions

Campath

Study Description

Brief Summary: 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.

Detailed Description: 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.