Understanding the immune response in chronic Graft Versus Host Disease after stem cell transplantation
Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
This study is trying to learn more about the immune system's response in people with chronic Graft Versus Host Disease after a stem cell transplant to find better ways to treat it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Pessac) |
| Trial ID | NCT06247150 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune landscape associated with chronic Graft Versus Host Disease (cGVHD) following allogeneic stem cell transplantation. It aims to analyze the presence of specific immune cells, particularly T follicular helper (TFH) cells, and their interactions with B cells in cGVHD-affected tissues. By obtaining blood samples and biopsies from patients, the study seeks to identify tertiary lymphoid structures that may play a role in the disease's pathogenesis. The findings could lead to better understanding and treatment strategies for cGVHD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 who have undergone allogeneic stem cell transplantation and have evidence of chronic Graft Versus Host Disease.
Not a fit: Patients under 18 years old or those currently on high-dose systemic steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved therapies for patients suffering from chronic Graft Versus Host Disease.
How similar studies have performed: Previous studies have shown success in understanding immune responses in related conditions, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pessac
- CHU de Bordeaux, Service d'Hématologie Clinique et Thérapie Cellulaire — Pessac, France (Recruiting)
Study contacts
- Study coordinator: Edouard FORCADE
- Email: edouard.forcade@chu-bordeaux.fr
- Phone: +33557656511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.