ALLO-SCT in Elderly Patients With Hematological Disease

NCT04386928 | Completed

• 1 other identifier: GITMO-AlloElderly
• Study Type: observational
• Target: 1,996
• Locations: 1 country
• Sites: 29

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.

Conditions

Hematologic Diseases; Stem Cell Transplant Complications

Keywords

Allogeneic stem cell transplantation; Elderly; Retrospective survey; GITMO; Hematological disease

Outcome Measures

Primary Outcomes (4)

• Overall Survival (OS)

  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

  These outcome measures will be assessed at 5 years from allo-SCT.

• Disease Free Survival (DFS)

  DFS is defined as the probability of being alive free of disease at any point in time.

  These outcome measures will be assessed at 5 years from transplant

• Transplant Related Mortality (TRM)

  TRM was defined as death due to any transplantation-related cause other than disease relapse

  These outcome measures will be assessed at 5 years from transplant

• Relapse risk (RR)

  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.

  These outcome measures will be assessed at 5 years from transplant.

Secondary Outcomes (2)

• Acute Graft-versus-Host Disease

  These outcome measures will be assessed at 100 days from transplant

• Chronic Graft-versus-Host Disease

  These outcome measures will be assessed at 5 years from transplant

Study Arms (1)

Elderly patients with hematological disease

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Absence of informed consent

Sponsors & Collaborators

• Gruppo Italiano Trapianto di Midollo Osseo: lead
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator

Study Sites (29)

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Ancona, Italy

Location

Ospedale Mazzoni

Ascoli Piceno, Italy

Location

Policlinico di Bari-Ematologia con trapianti

Bari, Italy

Location

Ospedale San Orsola

Bologna, Italy

Location

Ospedale Regionale Generale- Divisione Ematologia

Bolzano, Italy

Location

ASST Spedali Civili

Brescia, Italy

Location

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

Cagliari, Italy

Location

Azienda Ospedaliera di Careggi

Florence, Italy

Location

Osp. Card. Panico

Lecce, Italy

Location

Ospedale dell'Angelo

Mestre, Italy

Location

Ospedale Maggiore - Policlinico

Milan, Italy

Location

Ospedale Niguarda Ca' Grande

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -

Modena, Italy

Location

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

Monza, Italy

Location

A.O.U. San Luigi Gonzaga

Orbassano, Italy

Location

IRCCS Policlinico S. Matteo

Pavia, Italy

Location

Ospedale Civile

Pescara, Italy

Location

Ospedale G. Da Saliceto di Piacenza

Piacenza, Italy

Location

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

Reggio Calabria, Italy

Location

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

Roma, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

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

Roma, Italy

Location

AOU S. Giovanni di Dio e Ruggi d'Aragona

Salerno, Italy

Location

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

San Giovanni Rotondo, Italy

Location

Ospedale Moscati

Taranto, Italy

Location

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

Torino, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

Ospedale S. Bortolo-Divisione Ematologia

Vicenza, Italy

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Michele Malagola, MD

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 13, 2020
• Study Start: April 1, 2019
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

IT (29)