Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients

B-Cell Lymphomas Clinical Trial

Official title: Ofatumumab as Part of the Reduced Intensity Conditioning Regimen (RIC) for Patients With High Risk B Non Hodgkin's Lymphoma Undergoing Allogeneic Hematopoietic Cell Transplantation

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• B-Cell Lymphomas
• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT01613300
• Study type: Interventional
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Status: Completed
• Phase: Phase 2
• Start date: April 4, 2012
• Completion date: June 2020