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.
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
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Partial and complete remission, overall response rates
At 2 years
Norbert Claude GORIN, MD, PhD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health