NCT00587847

Campath Maintenance in Chronic Lymphocytic Leukemia

Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Campath	Campath 30 mg administered subcutaneously at varying intervals for up to 1 year

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-01-08
• Last updated: 2015-10-15
• Results posted: 2015-10-15

Locations

1 site across 1 country: United States