Status:
COMPLETED
Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Lymphocytic Leukemia
Eligibility:
All Genders
15+ years
Phase:
PHASE1
PHASE2
Brief 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 w...
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 a...
Eligibility Criteria
Inclusion
- Patients older than 15 years
- Refractory ALL
- ALL in relapse post chemotherapy or post transplant
- ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
- Signed informed consent
- Patients under social security coverage
- Anti conceptional tablets in pre menopausal women.
Exclusion
- Children below 15 years of age or aged 15
- Blast cells not expressing CD52 antigen (at all evaluations)
- HIV positivity
- ECOG Score 3 and 4
- Hypersensitivity to Alemtuzumab.
- Pregnancy or breast feeding.
- Other malignant disease in addition to ALL.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00773149
Start Date
October 1 2006
End Date
July 1 2011
Last Update
July 26 2012
Active Locations (1)
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1
Saint Antoine Hospital, Hematology Unit
Paris, France, 75012