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
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
5 years follow-up
Yes
Maria Dolores Caballero, MD
Principal Investigator
Hospital Clinico de Salamanca
Spain: Spanish Agency of Medicines
GELTAMO-O-CRT-2011
NCT01613300
May 2012
June 2017
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