Chronic Graft Versus Host DiseaseTIL-GVHDNCT06247150
Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
A study testing Additional blood sample and cGVHD target tissue biopsy in people with Chronic Graft Versus Host Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Additional blood sample and cGVHD target tissue biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2024to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux, Service d'Hématologie Clinique et Thérapie Cellulaire
Pessac
Edouard FORCADE, edouard.forcade@chu-bordeaux.fr
About this study
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.
Read the detailed description
Context :
Chronic Graft versus Host Disease (cGVHD) represents the main cause of morbidity and mortality in patients undergoing hematopoietic stem cell transplantation (alloSCT), occurring in 30 and 60%. Translational studies showed that different alloreactive T cell subsets were involved and associated with cGVHD, and regulatory subsets were deficient. Several homeostatic abnormalities of B cell subsets were also shown, which, in the context of high BAFF level, contributed to autoreactive B cell clone emergence.
In alloSCT patients, we observed (Forcade et al, Blood 2016) in the blood, a T cell subset called TFH, with B cell help capacity, similar to germinal center reaction. During cGVHD, blood TFH were highly activated, skewed toward a Th1/Th17 profile, and presented enhanced capacity to provide " help " to B cells, promoting auto-/allo-antibody production in the context of cGVHD. This was associated with increased level of CXCL13 in such patients, suggesting homing of this subset to lymphoid tissues.
Liarski et al (Sci Trans Med 2014) showed that TFH were observed in inflamed tissue sample from patients with lupus, and demonstrated close interaction with B cells, mimicking germinal center structures, such as tertiary lymphoid organs.
Preliminary data, on cGVHD tissue target, showed a CD4+ T cell infiltrate, of which some expressed CXCR5, ICOS, PD1 in single staining.
Hypothesis : cGVHD target tissue contains tertiary lymphoid structures.
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- Additional blood sample, cGVHD target tissue biopsy
- Keywords
- Chronic GVHD, Biopsy, TFH, Tertiary lymphoid structures
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Tertiary Lymphoid Structures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood sampleBiological
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 biopsyBiological
For chronic GVH patients only, cGVHD target tissue biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients with cGVHD | Other | Not described Receives: Biological: Additional blood sample; Biological: cGVHD target tissue biopsy |
| Patients without cGVHD | Other | Not described Receives: Biological: Additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start21 May 2024
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247150
- Sponsor's protocol ID
- CHUBX 2021/15
- Acronym
- TIL-GVHD
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No