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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CABYC
• Collaborator: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Alemtuzumab

Criteria

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.