Second and Further Allogeneic Stem Cell Transplantation Following Relapse After Allogeneic Transplant in Haematological Malignancies: Retrospective Results of the GETH
It reviewed 350 patients who underwent allogeneic 2 or more between the beginning of
monitoring and the end of 2009, end of follow-up. Is a multicenter study of row should
include all possible patients who take the appropriate data. To all centers contributing
patients to the study, were asked to fill out basic information related to the data sheets
of the EBMT report (MED-A and MED-B).
To collect these forms of EBMT, patients have previously authorized through the informed
consent of this information collection.
It will include basic descriptive characteristics of the cohort and comparisons between
groups were conducted to check if the sample is homogeneous.
The analysis is divided into descriptive data collection related to the transplant, both
prior to transplantation and on during it. It also collected data related to transplant once
done this.
FINDINGS AND PURPOSE The main variables to be analyzed are: overall survival, disease-free
survival and progression, relapse rate and transplant-related mortality.
Secondary endpoints to be analyzed can vary once made the data collection. Yet between them
will include: incidence of graft-versus-host disease (both acute and chronic), incidence of
infections.
The purpose of this study is the description of variables that can predict the success or
failure of making a second allogeneic transplant after the first relapse. These variables
were also analyzed for third or subsequent transplants.
Also seeks to differentiate risk groups among patients. The novelty of this study could
provide regarding previously published studies is the description of third or subsequent
transplants, so far there are few references to this in the literature to date.
FINANCING This study does not require funding.
CONFLICT OF INTEREST There is no conflict of interest
DATA COLLECTION PERIOD AEMET submission and acceptance: 1-2 months. Aceppt (SEPT-10-2010)
Data collection: 3 - 6 months Results: at 6 - 9 months Publication and presentation at
conferences, at 12 months
Observational
Time Perspective: Retrospective
Duarte R Palomino, MD
Principal Investigator
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Spain: Spanish Agency of Medicines
GET-ALO-2010-01
NCT01212796
September 2010
June 2011
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