The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
High risk: Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive) Low risk: Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Vall de Hebron
Barcelona, Barcelona, Spain
ICO Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Analyze the results of incidence and severity of acute and chronic GVHD
Time frame: 3 years
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Hospital Clinic i Provincial.
Barcelona, Catalonia, Spain
Hospital La Princesa
Madrid, Madrid, Spain
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Morales Meseguer
Murcia, Murcia, Spain
Hospital Clinico de Valencia
Valencia, Valencia, Spain