The aim of this study is rate of acute graft-versus-host disease II-IV measured at day +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant
In addition to above: * Rate of progression-free survival (PFS) at 12, 24, 36 and 60 months post-transplant defined as the time between the infusion of progenitors and the disease progression or death. Patients alive or in complete remission will be censored at the time of last follow up * Transplant-related mortality (TRM) at 12, 24, 36 and 60 months after transplantation, defined as any death not caused directly by lymphoma (any death caused by complications related to transplantation). * Overall survival (OS) defined as the time between infusion of progenitors and the patient's death from any cause. Alive Patients will be censored at the time of last follow-up * Incidence of chronic graft versus host disease (GVHD) wide at 1 and 5 years according to conventional criteria (Atkinson et al. 1989) and Filipovich et al. (BBMT, 2005). * Rate of event-free survival (DFS) defined as time interval between diagnosis of lymphoma and lymphoma progression or relapse or death if the above does not occur. * Successful graft implantation: is defined as: 1. º: three consecutive days with absolute neutrophil count greater than 0.5 \* 109 / L 2. ° thrombocythemia exceeds 20 \* 109 / L. * Reconstitution of the immune system: lymphocyte count populations CD20, CD3, CD4 and CD8 and immunoglobulinemia serum (days +100, 180, 360, 18 months and 24 months). * intercurrent infections. All sorts of infections (viral, fungal and bacterial)will be recorded * Safety assessment by the standards of Common Terminology Criteria for adverse events v. 4.0
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Reina Sofia
Córdoba, Spain
H.U. 12 de Octubre,
Madrid, Spain
H.U. Gregorio Marañón,
Madrid, Spain
Rate of acute grade II-IV graft-versus-host disease at 1 year
According to conventional criteria. This endpoint will be descriptively reported. Confidence intervals (95% bounds) will be provided. The rate will be analyzed in all patients enrolled at the clinical trial and that no major violation has been produced.
Time frame: 5 years follow-up
To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary
To analyze the complete response rate after treatment
Time frame: 5 years follow up
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H.U. La Paz
Madrid, Spain
Complejo Hospitalario Carlos Haya
Málaga, Spain
H. Morales Meseguer.
Murcia, Spain
H. Clinico de Salamanca
Salamanca, Spain
Hospital Virgen del Rocío
Seville, Spain
H. La Fe
Valencia, Spain