High Resolution Donor Recipient HLA Matching Level in Unrelated HSCT

NCT02827149 | Completed DMC

• 1 other identifier: GITMO-HLA-HR
• Study Type: observational
• Target: 1,838
• Locations: 1 country
• Sites: 39

Brief Summary

Italian, retrospective, prospective, observational, multicentre, spontaneous, non-interventional, non-pharmacological The study aims to analyze in the national Italian experience

1. 1.The compatibility level selected by the Italian Transplant Centres using an high resolution HLA typing at the start of search process for hematopoietic stem cell transplantation from volunteer unrelated donor
2. 2.The transplant outcomes in terms of Overall Survival, Disease Free Survival, Relapse Rate and Transplant Related Mortality and the correlation with the level of HLA matching pairs of donor/recipient included in the Italian Bone Marrow Donor Registry and Promise registry.
3. 3.The possible identification of allelic mismatching combinations characterized by increased cross-reactivity associated with higher incidence of acute or chronic graft-versus-host disease .
4. 4.The possible identification of combinations of allelic mismatching characterized by higher permissiveness.

Conditions

Hematologic Diseases

Keywords

HSCT; high resolution HLA typing; unrelated donor

Outcome Measures

Primary Outcomes (5)

• compatibility level

  The compatibility level selected by the Italian Transplant Centres using an high resolution HLA typing at the start of search process for Hematopoietic Stem Cell Transplantation from volunteer unrelated donor

  4 months by Activation of the donor search

• Overall survival from transplant

  The transplant outcomes in terms of Overall Survival and the correlation with the level of HLA matching pairs of donor/recipient included in the Italian Bone Marrow Donor and Promise Registry.

  100 days, 1 year and 2 years from transplant

• Disease Free Survival

  The transplant outcomes in terms of Disease Free Survival and the correlation with the level of HLA matching pairs of donor/recipient included in the Italian Bone Marrow Donor and Promise Registry

  100 days, 1 year and 2 years from transplant

• Relapse Rate

  The transplant outcomes in terms of Relapse Rate and the correlation with the level of HLA matching pairs of donor/recipient included in the Italian Bone Marrow Donor and Promise Registry.

  100 days, 1 year and 2 years from transplant

• Transplant Related Mortality

  The transplant outcomes in terms of Transplant Related Mortality and the correlation with the level of HLA matching pairs of donor/recipient included in the Italian Bone Marrow Donor and Promise Registry.

  100 days, 1 year and 2 years from transplant

Secondary Outcomes (4)

• identification of allelic mismatching

  2 years from transplant

• identification of allelic mismatching

  2 years from transplant

• Acute Graft-versus-Host Disease (aGvHD)

  from date of transplant to until the date of first event of aCGVD assessed up to 100 days post transplant]

• Chronic Graft-versus-Host Disease (cGvHD)

  from day +100 post transplant to until the date of first event to cGVHD assessed up to 2 years post enrolment]

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enrol adult patients who received hematopoietic stem cell transplantation (HSCT) from unrelated adult donor between 1° January 2012 and 31 December 2015.

You may qualify if:

• Haematological disease
• Written and signed PROMISE informed consent
• Patient undergoing unrelated HSCT

You may not qualify if:

• Unavailability of HR-HLA pairs typing including at least A, B, C, DRB1 loci

Sponsors & Collaborators

• Gruppo Italiano Trapianto di Midollo Osseo: lead
• Associazione Italiana di Immunogenetica e Biologia dei Trapianti (AIBT): collaborator
• National Marrow Donor Program: collaborator
• University of Rome Tor Vergata: collaborator

Study Sites (39)

Azienda Ospedaliera SS Antonio e Biagio

Alessandria, Italy

Location

Clinica di Ematologia - Ospedali Riuniti di Ancona

Ancona, Italy

Location

Ospedale Mazzoni

Ascoli Piceno, Italy

Location

Policlinico di Bari-Ematologia con trapianti

Bari, Italy

Location

Divisione di Ematologia - Ospedali Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale San Orsola

Bologna, Italy

Location

AO Spedali Civili di Brescia- USD - TMO Adulti

Brescia, Italy

Location

Ospedale Binaghi

Cagliari, Italy

Location

Ospedale Ferrarotto - Ematologia

Catania, Italy

Location

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

Cuneo, Italy

Location

Cattedra di Ematologia - Azienda Ospedaliera di Careggi

Florence, Italy

Location

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

Foggia, Italy

Location

AOU IRCCS San Martino - IST

Genova, Italy

Location

Divisione di Ematologia - Istituto Nazionale dei Tumori

Milan, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

IEO

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -

Modena, Italy

Location

Ospedale San Gerardo

Monza, Italy

Location

A.O.U. Policlinico Federico II

Napoli, Italy

Location

AO Ospedali Riuniti Villa Sofia - Cervello

Palermo, Italy

Location

Dipartimento Oncologico La Maddalena

Palermo, Italy

Location

Fondazione IRCCS San Matteo

Pavia, 27100, Italy

Location

Policlinico San Matteo

Pavia, Italy

Location

Dip. Medicina Clinica e Sperimentale

Perugia, 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

A.O. San Camillo Forlanini

Roma, Italy

Location

Cattedra di Ematologia - Policlinico

Roma, Italy

Location

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

Roma, Italy

Location

Policlinico Universitario Tor Vergata

Roma, Italy

Location

Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas

Rozzano (MI), Italy

Location

Ospedale Moscati

Taranto, Italy

Location

AOU CIttà della Salute e della Scienza

Torino, Italy

Location

Ospedale Regina Margherita

Torino, Italy

Location

Clinica Ematologica - AOU Santa Maria Della Misericordia

Udine, Italy

Location

AOU Integrat

Verona, Italy

Location

Ospedale S. Bortolo-Divisione Ematologia

Vicenza, Italy

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Alessandra Picardi, MD

  Policlinico Università Tor Vergata - Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 21, 2018
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

IT (39)