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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Additional blood sample

    Biological/Vaccine

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

  • cGVHD target tissue biopsy

    Biological/Vaccine

    For chronic GVH patients only, cGVHD target tissue biopsy

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Patients with cGVHDOther 2 interventions
Group B: Patients without cGVHDOther 1 intervention

Trial outcomes

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

Time frame
At inclusion visit

Secondary outcomes

Other outcomes

Sponsors and contacts

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