NCT06247150 Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
| NCT ID | NCT06247150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Chronic Graft Versus Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-05-21 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06247150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Graft Versus Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06247150 currently recruiting?
Yes, NCT06247150 is actively recruiting participants. Contact the research team at edouard.forcade@chu-bordeaux.fr for enrollment information.
Where is the NCT06247150 trial being conducted?
This trial is being conducted at Pessac, France.
Who is sponsoring the NCT06247150 clinical trial?
NCT06247150 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 70 participants.