ALLO-SCT in Elderly Patients With Hematological Disease

NCT ID: NCT04386928

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1996 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-03-16

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.

Conditions

Hematologic Diseases; Stem Cell Transplant Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Elderly patients with hematological disease

older than 60 years who received hematopoietic stem cell transplantation (HSCT)

No interventions assigned to this group

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: collaborator

Gruppo Italiano Trapianto di Midollo Osseo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Malagola, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Spedali Civili di Brescia

Locations

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Ancona, , Italy

Ospedale Mazzoni

Ascoli Piceno, , Italy

Policlinico di Bari-Ematologia con trapianti

Bari, , Italy

Ospedale San Orsola

Bologna, , Italy

Ospedale Regionale Generale- Divisione Ematologia

Bolzano, , Italy

ASST Spedali Civili

Brescia, , Italy

CTMO PO "Businco" A.O. "G. Brotzu"

Cagliari, , Italy

Azienda Ospedaliera di Careggi

Florence, , Italy

Osp. Card. Panico

Lecce, , Italy

Ospedale dell'Angelo

Mestre, , Italy

Ospedale Maggiore - Policlinico

Milan, , Italy

Ospedale Niguarda Ca' Grande

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -

Modena, , Italy

ASST Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano

Monza, , Italy

A.O.U. San Luigi Gonzaga

Orbassano, , Italy

IRCCS Policlinico S. Matteo

Pavia, , Italy

Ospedale Civile

Pescara, , Italy

Ospedale G. Da Saliceto di Piacenza

Piacenza, , Italy

Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli

Reggio Calabria, , Italy

Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli

Roma, , Italy

Policlinico Umberto I

Roma, , Italy

U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni

Roma, , Italy

AOU S. Giovanni di Dio e Ruggi d'Aragona

Salerno, , Italy

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Ospedale Moscati

Taranto, , Italy

A.O.U. Citta della Salute e della Scienza

Torino, , Italy

Clinica Ematologica - Policlinico Universitario

Udine, , Italy

Ospedale S. Bortolo-Divisione Ematologia

Vicenza, , Italy

Countries

Italy

Other Identifiers

GITMO-AlloElderly

Identifier Type: -

Identifier Source: org_study_id