NCT00773149

Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia

Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant. The use of G-CSF is justified by a possible increase in ADCC.

Detailed description

All patients receive Alemtuzumab in 3 successive phases: Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance. Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented. Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Alemtuzumab (CAMPATH 1H) associated to G-CSF	All patients receive Alemtuzumab in 3 successive phases: Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance. Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented. Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.

Timeline

• Start date: 2006-10-01
• Primary completion: 2011-01-01
• Completion: 2011-07-01
• First posted: 2008-10-16
• Last updated: 2012-07-26

Locations

1 site across 1 country: France