Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Hematologic Diseases Clinical Trial

— MetAlloLip  

Official title:

Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918343
• Other study ID #: P/2018/387
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: March 2024

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Charline Vauchy, PhD
• Phone: +33381218875
• Email: cvauchy[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: March 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Hematologic malignancy in complete remission
• Patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
• Regular follow-up in the center

Exclusion Criteria:

• Treatment with a statin in progress
• Umbilical cord blood transplantation
• Hemoglobin level less than or equal to 8g / dl
• Known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion.
• Chronic enteropathy with Clostridium Difficile

Related Conditions & MeSH terms

• Graft vs Host Disease
• Hematologic Diseases
• Stem Cell Transplantation

Intervention

Other:
• Blood sample
blood samples (4 times; 14ml per visit)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	Centre Hospitalier Universitaire de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the ROC curve for PLTP in the occurrence of GVHD	Area under the ROC curve (AUCROC) for PLTP assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.	3 months
Primary	Area under the ROC curve for LPS in the occurrence of GVHD	Area under the ROC curve (AUCROC) for LPS assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.	3 months