Hematopoietic Stem Cell Transplantation
Conditions
Keywords
HSCT, intestinal dysbiosis, immune reconstitution
Brief summary
Preliminary (proof of concept), monocentric, interventional, prospective, non-randomized and analytic trial designed to simultaneously explore intestinal microbiota changes and early post-transplant immune reconstitution, and to correlate biological data with clinical data (antibiotics use, stress level, GVHD).
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the major curative therapeutic approach for hematologic neoplasms. After HSCT, patients have a compromised GI mucosal barrier and an altered microbiota, also called dysbiosis. The later could be due to conditioning or use of broad-spectrum antibiotics, and could be accentuate by stress encountered by patients during their therapy management. Recent data have shown that alterations in the intestinal flora are associated with bad outcome, particularly with graft-versus-host disease (GVHD), bacteremia, and reduced overall survival post-transplantation. How intestinal bacteria can modulate the risk of relapse after HSCT is yet unknown. The scientists hypothesize that the variation of some bacterial taxa may influence post-transplant immune reconstitution, particularly invariant Natural Killer T cells.
Interventions
BIOLOGICALblood samples
20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
BIOLOGICALfecal samples
1 g of feces (D-8, D0, D15, D30, D90)
BEHAVIORALAnxiety test
Test of Spielberger
BEHAVIORALStress test
Test of Cohen
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years affiliated to a social security system * Patients followed at the hospital of Nancy for a allogeneic hematopoietic cell transplantation (HLA matched donor) * Graft of peripheral blood stem cell * GVHD prophylaxis by ciclosporin and antilymphocyte serum +/- mycophenolate mofetil or methotrexate.
Exclusion criteria
* HIV+ patients * Patients with active HBV or HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of iNKT reconstitution after HSCT (good/poor) | Day 90, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immune reconstitution after HSCT (other immune cells) | Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2 | quantification of Tregs, MDSC, MAIT, T lymphocytes |
| GVH disease | Day 30, Day 60, Day 90 | yes/not |
| use of antibiotics | Day 0, Day 15, Day 30, Day 60, Day 90 | yes/not (molecules, delay, posology) |
| gut microbiota composition | Day 0, Day 15, Day 30, Day 90 | relative abundance of intestinal bacterial taxa |
| level of anxiety | Day -8, Day 15, Day 30, Day 90 | test of Spielberger |
| quality of iNKT reconstitution after HSCT (good/poor) | Day 15, Day 30, Day 60, Day 180, Year 1, Year2 | — |
| level of stress | Day -8, Day 15, Day 30, Day 90 | test of Cohen |
Countries
France
Contacts
Primary ContactCorentine ALAUZET, Dr
Backup ContactMarie-Thérèse RUBIO, Pr
Outcome results
None listed