Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (… (NCT06247150) | Clinical Trial Compass
RecruitingNot Applicable
Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
France70 participantsStarted 2024-05-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To describe immune landscape in chronic GVHDtarget tissuesubsets, especially TFH, within cGVHD tissue target, using flow cytometry and histology