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Alemtuzumab

Antineoplastic Agents, Immunological

High risk patients (at least one GVHD high risk criterion):

Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive).

Low Risk patients (no GVHD high risk criterion):

Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).

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).

Rafael Duarte, MD, Ph.D

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.

Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning	NCT00781781	Graft Versus Ho...	Alemtuzumab	40 Years - 65 Years	CABYC
Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning	NCT00781781	Graft Versus Ho...	Alemtuzumab	40 Years - 65 Years	CABYC
Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning	NCT00781781	Graft Versus Ho...	Alemtuzumab	40 Years - 65 Years	CABYC
Alemtuzumab Use (MabCampath®) in Hematopoietic Transplant of Unrelated Donor With Reduced Intensity Conditioning	NCT00781781	Graft Versus Ho...	Alemtuzumab	40 Years - 65 Years	CABYC

Spots Global Cancer Trial Database for myeloid and lymphoid malignances