Multicenter, Openlabel, Phase II Intergroups (GELTAMO/GETH) Trial, on the Use of Alemtuzumab for Unrelated Donor Reduced Intensity Conditioning Allogenic Transplant in Hematological Malignancies Patients
Each patient will be assigned to one of the two dosing schedules and total dose of drug
envisaged in the study. The assignation to conventional or reduced Alemtuzumab (MabCampath)
dose will be done depending on the age and risk of suffering GVHD, in function of variables
coming from general experience.
High risk of GVHD criteria:
Gender incompatibility: male patient of female donor. HLA incompatibility: non identical
high resolution typing in HLA A, B, C, DRB1, DQB1 (identity less than 10/10 alleles by high
resolution) Age of patient more or equal than 55 years
Conventional doses in high risk (at least one criterion of GVHD high risk):
100 mg de Alemtuzumab IV total dose in 5, 20 mg fractions, days -8, -7, -6, -5 and -4.
Reduced dose in low risk cases (no criteria of GVHD high risk):
50 mg de Alemtuzumab IV total dose en 5 fractions of 10 mg, days -5, -4, -3, -2 and -1.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Analyze the results of incidence and severity of acute and chronic GVHD
Rafael Duarte, MD, Ph.D
ICO Bellvitge. Hospital Duran i Reynals
Spain: Spanish Agency of Medicines