Clinical trial

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

Name
CHUBX 2021/15
Description
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.
Trial arms
Trial start
2024-05-21
Estimated PCD
2026-05-01
Trial end
2026-06-01
Status
Recruiting
Treatment
Additional blood sample
The procedure will consist of an additional blood sample for 3 ETDA tubes collection (NGS analysis) and citrate tube collection (NETose analysis)
Arms:
Patients with cGVHD, Patients without cGVHD
cGVHD target tissue biopsy
For chronic GVH patients only, cGVHD target tissue biopsy
Arms:
Patients with cGVHD
Size
70
Primary endpoint
To describe immune landscape in chronic GVHDtarget tissuesubsets, especially TFH, within cGVHD tissue target, using flow cytometry and histology
At inclusion visit
Eligibility criteria
Inclusion Criteria: * Patient \> 18 yo ; * Having undergone an allogeneic stem cell tranplant ; * 2 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; Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2024-05-30

1 organization

2 products

1 indication

Product
cGVHD