Clinical trial NCT04386928: ALLO-SCT in Elderly Patients With Hematological Disease
Official title: Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Stem Cell Transplant Complications
Keywords: Allogeneic stem cell transplantation
Elderly
Retrospective survey
GITMO
Hematological disease
Lead sponsor: Gruppo Italiano Trapianto di Midollo Osseo
Sponsor class: OTHER
Collaborators: name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
First posted: 2020-05-13
Enrollment: 1996
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enrol patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Allogeneic transplantation from 2000 to 2017 (for patients submitted to more than one transplant, only the first transplant will be considered)
* Informed consent

Exclusion Criteria:

* Absence of informed consent

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: These outcome measures will be assessed at 5 years from allo-SCT.
measure: Disease Free Survival (DFS)
timeFrame: These outcome measures will be assessed at 5 years from transplant
measure: Transplant Related Mortality (TRM)
timeFrame: These outcome measures will be assessed at 5 years from transplant
measure: Relapse risk (RR)
timeFrame: These outcome measures will be assessed at 5 years from transplant.
Secondary outcomes:
measure: Acute Graft-versus-Host Disease
timeFrame: These outcome measures will be assessed at 100 days from transplant
measure: Chronic Graft-versus-Host Disease
timeFrame: These outcome measures will be assessed at 5 years from transplant
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Ascoli Piceno
country: Italy
facility: Ospedale Mazzoni
city: Bari
country: Italy
facility: Policlinico di Bari-Ematologia con trapianti
city: Bologna
country: Italy
facility: Ospedale San Orsola
city: Bolzano
country: Italy
facility: Ospedale Regionale Generale- Divisione Ematologia
city: Brescia
country: Italy
facility: ASST Spedali Civili
city: Cagliari
country: Italy
facility: CTMO PO "Businco" A.O. "G. Brotzu"
city: Firenze
country: Italy
facility: Azienda Ospedaliera di Careggi
city: Lecce
country: Italy
facility: Osp. Card. Panico
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
city: Milano
country: Italy
facility: Ospedale Maggiore - Policlinico
city: Milano
country: Italy
facility: Ospedale Niguarda Ca' Grande
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Modena
country: Italy
facility: Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
city: Monza
country: Italy
facility: ASST Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: Pescara
country: Italy
facility: Ospedale Civile
city: Piacenza
country: Italy
facility: Ospedale G. Da Saliceto di Piacenza
city: Reggio Calabria
country: Italy
facility: Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
city: Roma
country: Italy
facility: Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni
city: Salerno
country: Italy
facility: AOU S. Giovanni di Dio e Ruggi d'Aragona
city: San Giovanni Rotondo
country: Italy
facility: Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
city: Taranto
country: Italy
facility: Ospedale Moscati
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza
city: Udine
country: Italy
facility: Clinica Ematologica - Policlinico Universitario
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo-Divisione Ematologia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Michele Malagola, MD
role: PRINCIPAL_INVESTIGATOR
References: