ALLO-SCT in Elderly Patients With Hematological Disease

Sponsor

Gruppo Italiano Trapianto di Midollo Osseo (Other)

Overall Status

Completed

CT.gov ID

NCT04386928

Collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)

1,996

Enrollment

Locations

23.5

Actual Duration (Months)

68.8

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases Stem Cell Transplant Complications

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1996 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Mar 16, 2021

Actual Study Completion Date :

Mar 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Elderly patients with hematological disease older than 60 years who received hematopoietic stem cell transplantation (HSCT)

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [These outcome measures will be assessed at 5 years from allo-SCT.]
is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis
Disease Free Survival (DFS) [These outcome measures will be assessed at 5 years from transplant]
DFS is defined as the probability of being alive free of disease at any point in time.
Transplant Related Mortality (TRM) [These outcome measures will be assessed at 5 years from transplant]
TRM was defined as death due to any transplantation-related cause other than disease relapse
Relapse risk (RR) [These outcome measures will be assessed at 5 years from transplant.]
The relative risk (RR) or risk ratio is the ratio of the probability of an outcome in an exposed group to the probability of an outcome in an unexposed group.

Secondary Outcome Measures

Acute Graft-versus-Host Disease [These outcome measures will be assessed at 100 days from transplant]
cumulative incidence of acute GvHD (grade II-IV)
Chronic Graft-versus-Host Disease [These outcome measures will be assessed at 5 years from transplant]
cumulative incidence and severity of chronic graft-versus-host disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Azienda Ospedaliero-Universitaria Ospedali Riuniti	Ancona	Italy
2	Ospedale Mazzoni	Ascoli Piceno	Italy
3	Policlinico di Bari-Ematologia con trapianti	Bari	Italy
4	Ospedale San Orsola	Bologna	Italy
5	Ospedale Regionale Generale- Divisione Ematologia	Bolzano	Italy
6	ASST Spedali Civili	Brescia	Italy
7	CTMO PO "Businco" A.O. "G. Brotzu"	Cagliari	Italy
8	Azienda Ospedaliera di Careggi	Firenze	Italy
9	Osp. Card. Panico	Lecce	Italy
10	Ospedale dell'Angelo	Mestre	Italy
11	Ospedale Maggiore - Policlinico	Milano	Italy
12	Ospedale Niguarda Ca' Grande	Milano	Italy
13	Ospedale San Raffaele	Milano	Italy
14	Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -	Modena	Italy
15	ASST Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano	Monza	Italy
16	A.O.U. San Luigi Gonzaga	Orbassano	Italy
17	IRCCS Policlinico S. Matteo	Pavia	Italy
18	Ospedale Civile	Pescara	Italy
19	Ospedale G. Da Saliceto di Piacenza	Piacenza	Italy
20	Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli	Reggio Calabria	Italy
21	Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli	Roma	Italy
22	Policlinico Umberto I	Roma	Italy
23	U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni	Roma	Italy
24	AOU S. Giovanni di Dio e Ruggi d'Aragona	Salerno	Italy
25	Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza	San Giovanni Rotondo	Italy
26	Ospedale Moscati	Taranto	Italy
27	A.O.U. Citta della Salute e della Scienza	Torino	Italy
28	Clinica Ematologica - Policlinico Universitario	Udine	Italy
29	Ospedale S. Bortolo-Divisione Ematologia	Vicenza	Italy