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

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).

    1. Disease that does not obtain a CR with Fludarabine or antiCD-20 including chemotherapy.
    2. Relapse after autologous transplant.
    3. Non candidates to autologous transplant in 2nd CR (e.g. mobilization failure, or persistent marrow infiltrate).
  • 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:

• Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO & FVC <40% of expected) function tests impairment.
• HIV injection.
• Absence of signed informed consent.
• Progressive disease previous to transplant or not fulfilling the above mentioned response criteria.
• Other co-morbidities that contraindicate CT.
• Pregnant and/or breast-feeding women or with pregnancy risk by inadequate contraception.
• Life expectancy <6 months.
• Mental or psychiatric deficiency impeding adequate understanding and consent to therapy
• Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the trial.
• Active infectious process.