Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)

NCT06247150 | Recruiting

• 1 other identifier: CHUBX 2021/15
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Graft versus Host Disease (GVHD) is frequent after allogeneic stem cell transplantation (alloSCT). GVHD occurs following 2 patterns : acute GVHD (aGVHD) or chronic GVHD (cGVHD). The latter occurs in nearly 50% of patients and its pathogenesis remains poorly understood. Previous translational studies have delineated biological immune dysregulation involved in cGVHD and facilitated the development of new drug and therapeutic strategies. New aspects of T and B cells collaboration in the context of cGVHD using blood description of a key player called TFH, classicaly involved in germinal center reaction, were previously uncovered (Forcade et al, Blood 2016). Previous studies in the context of auto-immune inflammation (lupus nephritis) or organ transplant rejection, suggested that target tissue could contain accessory lymphoid structures (TLS). The description of such structures in cGVHD target tissue would give the opportunity to directly analyze immune key player involved the pathogenesis of cGVHD.

Conditions

Chronic Graft Versus Host Disease

Keywords

Chronic GVHD; Biopsy; TFH; Tertiary lymphoid structures

Outcome Measures

Primary Outcomes (1)

• To describe immune landscape in chronic GVHDtarget tissuesubsets, especially TFH, within cGVHD tissue target, using flow cytometry and histology

  Flow cytometry and multiplex tissue imaging. GVHD evaluation using NIH score

  At inclusion visit

Study Arms (2)

Patients with cGVHD

OTHER

Biological: Additional blood sample; Biological: cGVHD target tissue biopsy

Patients without cGVHD

OTHER

Biological: Additional blood sample

Interventions

Additional blood sample BIOLOGICAL

The procedure will consist of an additional blood sample for 3 ETDA tubes collection (NGS analysis) and citrate tube collection (NETose analysis)

Patients with cGVHD; Patients without cGVHD

cGVHD target tissue biopsy BIOLOGICAL

For chronic GVH patients only, cGVHD target tissue biopsy

Patients with cGVHD

Eligibility Criteria

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

You may qualify if:

• Patient \> 18 yo ;
• Having undergone an allogeneic stem cell tranplant ;
• groups of patients will be eligible
• showing evidence of primary cGVHD or occuring after Donor Lymphocyte Infusion
• in the case of first occurrence of cGVHD, in the absence of any new systemic therapy ;
• in the case of recurrent cGVHD, steroid dose has to be below 15mg/day of Prednisone ;
• Having read, understood and signed an informed consent of the study;
• With social security affiliation;

You may not qualify if:

• Patient below 18 yo or unable to give consent ;
• Systemic therapy using steroids over 15mg/d of Prednisone ; and/or the use of other systemic agent introduced in the last month ;
• Haemorrhagic risk of biopsy anticipated ;
• Absence of patient agreement for the study

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, Service d'Hématologie Clinique et Thérapie Cellulaire

Pessac, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Tertiary Lymphoid Structures

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; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edouard FORCADE

CONTACT

+33557656511; edouard.forcade@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: May 21, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)