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
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
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.
Inclusion criteria:
Patients with haematological or lymphoid malignancies with allogenic transplantation indication:
High risk follicular NHL, mantle HHC and other low grade NHC (e.g lymphoplasmacytic, extranodal or from marginal zone).
Poor prognosis chronic lymphoblastic leukaemia (CLL): Del 11q, Del 17p, complex cariotype; B symptoms, progressive low cell count by marrow infiltration, lymphocytosis or enlarged lymph nodes, or progressive spleen growth.
High grade lymphoma transformed from a low grade non Hodgkin's lymphoma or from a chronic lymphocitic leukaemia
High risk T peripheral lymphoma, with IPI > or = 2, non susceptible of autologous transplant, or relapsed after autologous transplant
Primarily refractory high risk Hodgkin's disease, relapse in patients not susceptible of autologous transplant or relapse after autologous transplant.
High risk acute mieloblastic leukaemia (AML) in 1st CR, or AMC > or = 2 CR, including AML after MDS and secondary AML.
High risk acute lymphoblastic leukaemia (ALL) because of poor response to induction chemotherapy (>10% blasts day +14 or no RC day +28-35), or by cytogenetic criteria: Ph+ or 11q23.
High risk myelodisplastic syndromes (SMD) type RAEB-1 or AREB-2 with IPSS >Int-1.
For the inclusion in transplant patients with ALL or AML must be in CR, patients with MDS must have <10% blasts en la BM, and patients with lymphoid malignancies must show previous chemosensitivity, with PR or CR.
Patients 40 to 65 years old. Patients outside this age range could be included according to participating centres criteria.
Patients in the study population lacking a compatible related donor, and with a possible compatible unrelated donor (>=9/10 by 10 alleles high resolution typing: HLA-A, B, C, DRB1, DQB1) to assign the patients to a risk in subgroup.
Signed informed consent.
Not fulfilling any of the following exclusion criteria.
Exclusion Criteria: