DSAs in Patients Undergoing Allo-HSCT From Mismatched Donors
AIBT_DSAs
Donor-specific Anti-HLA Antibodies (DSAS) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation From Mismatched Donors
1 other identifier
observational
912
1 country
25
Brief Summary
Retrospective observational multicentric, spontaneous non-interventional non-pharmacological Italian study. The primary objective is analysis of Anti-HLA antibodies and DSAs searching and monitoring activities in haematological adult and paediatric patients undergoing allo-HSCT from January 2014 to June 2017. This study will evaluate approximately 1000 subjects (with competitive enrolment) from GITMO investigational centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2018
CompletedFirst Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2021
CompletedNovember 25, 2022
November 1, 2022
2.7 years
May 11, 2021
November 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Analysis of the monitoring practice of DSAs
The variables that will be collected are: Type of transplant in which the search for DSAs is carried out, Laboratory methods used, Positivity cut-off used, Donor selection criteria if DSAs present, Desensitization protocol employed
6 months from allogeneic hematopoietic stem cell transplantation
Role of DSAs on neutrophils and platelets engraftment
Time to reach an absolute neutrophil count \> 0.5 109/L from day of HSCT. Neutrophil recovery end-point will be defined as the first of 3 consecutive days with an absolute neutrophil count \> 0.5 x109/L. Time engraftment of platelet count will be defined as PTLS \>20.9 x 109/L without transfusion requirements for at least 5 days.
28 days from allogeneic hematopoietic stem cell transplantation
Graft failure
graft failure is defined as peripheral blood ANC \< 0.5 × 109/L by after allogeneic hematopoietic stem cell transplantation without evidence of relapse
28 days from allogeneic hematopoietic stem cell transplantation
Study Arms (1)
patients who underwent mismatched allogeneic transplantation
Pediatric and adult patients who underwent mismatched allogeneic transplantation, from January 2014 to June 2017.
Eligibility Criteria
Adult and children allogenic Hematopoietic stem cell transplantation recipients
You may qualify if:
- patients who underwent mismatched allogeneic transplantation, from January 2014 to June 2017
- signed the informed consent
You may not qualify if:
- Absence of consent Written information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Clinica di Ematologia. AOU Ospedali Riuniti di Ancona
Ancona, Italy
Policlinico di Bari-Ematologia con trapianti
Bari, Italy
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, Italy
Ospedale Seragnoli Malpighi
Bologna, Italy
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Azienda Ospedaliera di Careggi
Florence, Italy
AOU IRCCS San Martino - IST
Genova, Italy
Ospedale Gaslini
Genova, Italy
Div. di Ematologia e TMO, Istituto Nazionale Tumori
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Unità Operativa di Ematologia e Trapianto Midollo Osseo (UTMO), Ospedale San Raffaele di Milano
Milan, Italy
Azienda ospedaliera Santobono Pausilipon
Napoli, Italy
Azienda ospedaliera Universitaria di Parma
Parma, Italy
Fondazione IRCCS San Matteo
Pavia, 27100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Ospedale San Carlo
Potenza, Italy
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
Reggio Calabria, Italy
A.O. San Camillo Forlanini
Roma, Italy
Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli
Roma, Italy
Policlinico Tor Vergata
Roma, Italy
Policlinico Umberto I - Università La Sapienza
Roma, Italy
Azienda ospedaliera Città della Salute e della Scienza
Torino, Italy
Clinica Ematologica - AOU Santa Maria Della Misericordia
Udine, Italy
Policlinico GB Rossi
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Paola Iori
Azienda Policlinico Umberto I
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2021
First Posted
May 17, 2021
Study Start
October 15, 2018
Primary Completion
June 22, 2021
Study Completion
June 22, 2021
Last Updated
November 25, 2022
Record last verified: 2022-11