Acute Lymphocytic Leukemia Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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