Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04386928 |
| Other study ID # |
GITMO-AlloElderly |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
March 16, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Gruppo Italiano Trapianto di Midollo Osseo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Retrospective, observational, multicentre, spontaneous, non-interventional study This study
will evaluate all consecutive patients older than 60 years who received hematopoietic stem
cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.
Description:
The age of patients' population is increasing every year, as the life expectancy. Thus, the
incidence and prevalence of hematological cancers is increasing. In particular, acute
leukemias and myelodysplastic syndromes are the most frequent diseases of the hematopoietic
system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for
these diseases, and the number of allo-SCTs in the elderly is currently in progressive
growth. This is partially due to the improvement of the allo-SCT procedure over the years,
with the amelioration of donor selection, Human Leukocyte Antigen typing, graft versus host
disease (GVHD) and infections prophylaxis and treatment.
Nevertheless, there is still an unmet clinical need, represented by the lack of extensively
and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, the
investigators planned this retrospective analysis of allo-SCTs in patients older than 60
years, within the Gruppo Italiano Trapianti di Midollo Osseo transplant activity of the last
17 years. This study will help us in designing future prospective trials, including a
comprehensive geriatric assessment of frailty, in order to address to allo-SCT those elderly
who have the highest probability to achieve the best long term outcome with the lowest
transplant-related mortality and morbidity.
For patients submitted to more than one transplant, the first transplant will be considered
only and the record of these patients will be derived from the Gruppo Italiano Trapianti di
Midollo Osseo database and the European group for Blood and Marrow Transplantation database
(Promise), where all the transplant activity is regularly recorded.
Primary objective is description of the patients' population. This endpoint will particularly
focus on the changing, over the years, of the clinical and hematological characteristics of
elderly patients submitted to allo-SCT.
Secondary objectives are: description of the transplants' characteristics, such as the
conditioning regimens and the GVHD prophylaxis, description of acute and chronic graft versus
host disease (GVHD) incidence and treatment, description of overall survival (OS),
disease-free survival (DFS), transplant related mortality (TRM) and relapse risk (RR).
The sample size includes all the transplants recorded in the Gruppo Italiano Trapianti di
Midollo Osseo and European group for Blood and Marrow Transplantation database. The
statistical analysis will be descriptive, so the investigators don't need to calculate a
sample size for the study. This analysis will include:
- full description of patients and transplant characteristics. In this area, a specific
focus will be done on the pre-transplant comorbidity index, according to the most
commonly published risk-scores.
- focus on acute and chronic GVHD incidence and treatment.
- outcome description, with a focus on: Overall Survival, Disease Free Survival),
Transplant Related Mortality, relapse risk.
These outcome measures will be assessed at 1, 2 and 5 years from allo-SCT. The analysis of
the continuous and categorical variables will take place according to the criteria of the
descriptive statistics, including mean, median, standard deviation, range, minimum values and
maximum values for the continuous variables, absolute and relative values for the categorical
variables. For the comparison of continuous and categorical variables, parametric and
non-parametric statistical tests will be applied (Chi-square test, Fisher exact test and rank
correlation coefficient of Spearman).
This trial is being organized under the auspices of the Gruppo Italiano Trapianti di Midollo
Osseo that involves the principal Centres active in transplantation of any kind of
hematopoietic stem cells (HSCT) in Italy.
The study will be conducted according to the principles of Good Clinical Practice, the
current Italian and European laws and regulations, in agreement with the declaration of
Helsinki. The protocol has been written and the study will be conducted according to the The
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) Harmonized Tripartite Guideline for Good Clinical Practice, issued by the
European Union. The responsible Local Ethical Committee approval must be obtained before
starting the trial. A copy of the patient informed consent form must be submitted to the
appropriate authority or committee, together with the protocol for written approval. Written
approval of the protocol and informed consent by the responsible and appropriate authority or
committee must be obtained prior to recruitment of patients to the study.
