Survival in Myelofibrosis Patients After Allogeneic Hematopoietic Stem Cell Transplantation in Five Centers in France

Myelofibrosis Clinical Trial

— SYMFASCT  

Official title:

Survival in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Myelofibrosis in Five French Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282421
• Other study ID #: 2020PI014
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators would like to conduct a retrospective study in five centers in France in the goal to evaluate the survival of patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis.

Description:

The allogeneic stem cell transplantation is the only curative treatment for myelofibrosis. However, because of complications such as infection, graft-versus-host disease and conditioning toxicity, this procedure is associated with a high morbidity-mortality rate. The discovery of molecular and genetic markers permitted to improve therapeutic strategy and survival of patient in the last few years. In this study, the investigators want to make an overview of survival, incidence of relapse and incidence of acute and chronic graft versus host disease in allogeneic stem cell transplantation for myelofibrosis, in five centers in France, between 2007 and 2017.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 1, 2020
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: adult patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis in five centers in France (Nancy, Besancon, Strasbourg, Pitie Salpetriere and Lyon) between 2007 and 2017

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Exclusion Criteria:

• age < 18 years old

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (2)

Hussein K, Stucki-Koch A, Alchalby H, Triviai I, Kröger N, Kreipe H. Cytokine Expression Pattern in Bone Marrow Microenvironment after Allogeneic Stem Cell Transplantation in Primary Myelofibrosis. Biol Blood Marrow Transplant. 2016 Apr;22(4):644-650. doi: 10.1016/j.bbmt.2015.12.006. Epub 2015 Dec 19. — View Citation

Kröger N, Panagiota V, Badbaran A, Zabelina T, Triviai I, Araujo Cruz MM, Shahswar R, Ayuk F, Gehlhaar M, Wolschke C, Bollin R, Walter C, Dugas M, Wiehlmann L, Lehmann U, Koenecke C, Chaturvedi A, Alchalby H, Stadler M, Eder M, Christopeit M, Göhring G, Koenigsmann M, Schlegelberger B, Kreipe HH, Ganser A, Stocking C, Fehse B, Thol F, Heuser M. Impact of Molecular Genetics on Outcome in Myelofibrosis Patients after Allogeneic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1095-1101. doi: 10.1016/j.bbmt.2017.03.034. Epub 2017 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	incidence of survival in the cohort	at 1 year
Secondary	incidence of relapse	incidence of relapse in the cohort	at 1 year
Secondary	incidence of acute graft versus host disease	incidence of acute graft versus host disease in the cohort	at 3 months
Secondary	incidence of chronic graft versus host disease	incidence of chronic graft versus host disease in the cohort	at 1 year