Electronic Database for the Follow up of the ATG_FamilyStudy

NCT03042676 | Completed

• 1 other identifier: 271/2016/O/Oss
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of acute leukemias. The most important post-transplant complication is graft vs host disease (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number, NCT00678275). In the ATG\_familystudy (prospective, randomised, multicenter study) a decrease in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA identical sibling donor after myeloablative preparative regimen. In particular, the GVHD extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a minimum follow up of 2 years from transplant. The investigators would like to evaluate the longer term follow up of this study.

Conditions

GVHD, Chronic; Acute Leukemia; Stem Cell Transplant Complications

Keywords

anti-T lymphocytic globulin (ATG); allogeneic stem cell transplant; prophylaxis of GVHD

Outcome Measures

Primary Outcomes (1)

• cumulative incidence of cGVHD

  cumulative incidence according to Fine and Gray method, labeling death before the event of interest as a competing risk.

  cumulative incidence of cGVHD through study competition, an average of 24 months

Secondary Outcomes (1)

• Overall survival after allogeneic stem cell transplant

  overall survival through study competition, an average of 24 months

Other Outcomes (2)

• Cumulative incidence of relapse after allogeneic stem cell transplant

  Relapse Incidence through study competition, an average of 24 months

• Recovery of working activity

  Recovery of working activity after transplant anytime through study competition, an average of 24 months

Study Arms (2)

ATLG group

ATLG treatment for GVHD prophylaxis.

no ATLG group

No ATLG treatment.

Eligibility Criteria

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

Study Population

The electronic database will include all patients enrolled in the ATG\_familystudy (NCT00678275). Multicenter, observational, prospective cohorting study (electronic database) with a retrospective phase. Prospective phase: the electronic database will include patients enrolled in the ATG\_familystudy and routinely followed up at the Hematological Institutions participating to the study. Retrospective phase: data collection will review all patients enrolled in the ATG familystudy (medical chart review) and already dead or lost at follow up after the end of the ATG\_familystudy by medical chart review (Feb 2014)

You may qualify if:

• all patients already enrolled in the ATG\_family\_study (NCT00678275), and published by Kroger N et al. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N Engl J Med 2016;374:43-53
• informed consent given

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Hospital Clínico Universitario de Valencia: collaborator
• The Chaim Sheba Medical Center: collaborator

Study Sites (1)

Hematology - Sant'Orsola-Malpighi Hospital

Bologna, Bo, 40138, Italy

Location

Related Publications (2)

• Kroger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, Nagler A, Selleri C, Risitano A, Messina G, Bethge W, Perez de Oteiza J, Duarte R, Carella AM, Cimminiello M, Guidi S, Finke J, Mordini N, Ferra C, Sierra J, Russo D, Petrini M, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Bonifazi F. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N Engl J Med. 2016 Jan 7;374(1):43-53. doi: 10.1056/NEJMoa1506002.

  PMID: 26735993 RESULT

• Bonifazi F, Solano C, Wolschke C, Sessa M, Patriarca F, Zallio F, Nagler A, Selleri C, Risitano AM, Messina G, Bethge W, Herrera P, Sureda A, Carella AM, Cimminiello M, Guidi S, Finke J, Sorasio R, Ferra C, Sierra J, Russo D, Benedetti E, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Kroger N. Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study. Lancet Haematol. 2019 Feb;6(2):e89-e99. doi: 10.1016/S2352-3026(18)30214-X.

  PMID: 30709437 RESULT

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Francesca Bonifazi, MD

  St. Orsola-Malpighi University Hospital Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: February 3, 2017
• Study Start: September 15, 2017
• Primary Completion: June 8, 2018
• Study Completion: June 30, 2018
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)