Acute Leukemia, Hematopoietic Stem Cell Transplant (HSCT), Myelodysplastic Syndrome, Myelofibrosis
Conditions
Keywords
Peri-graft cytokine Profile, Influence of Hematologic Disease, Influence of Donor Type
Brief summary
Cytokine profiles in the early post-transplant phase may influence the Development of early post-transplant inflammatory or immunological complications. This study propose to analyze these cytokine profiles based on the disease (myelofibrosis or other hematologic malignancies) and on the donor type (haploidentical, genotypically identical, or phenotypically identical). Patients with myelofibrosis have an inflammatory cytokine profile prior to transplantation. Patients who undergo haploidentical allogeneic hematopoietic stem cell transplantation (HSCT) most often experience a post-transplant cytokine release syndrome, and the question is whether these two conditions-myelofibrosis and haploidentical transplantation-increase the probability of an early cytokine release, potentially putting these patients at greater risk for acute GVHD than patients who undergo transplantation under other conditions or who have other diseases. In the prospective Phase 2 "FIBRAPLO" protocol (ClinicalTrials.gov ID NCT04728490), 28 patients with myelofibrosis received an allogeneic hematopoietic stem cell transplantation from a haploidentical donor, and serum samples were collected at Day-7 before transplantation, Day 0 and Day+7 after transplantation to analyse cytokine profiles around the time of allogeneic HSCT. The purpose of the present study is to match these FIBRAPLO patients (patients with myelofibrosis who received an allograft from a haploidentical donor) with patients without myelofibrosis who received a haploidentical transplant, in order to determine whether these profiles are specific to this population. The aim is to compare these profiles to other scenarios: patients with or without myelofibrosis who received transplants from 10/10 or geno-identical donors. This study propose to prospectively collect blood samples at time points (D-7, D0, and D7) from control patients : * receiving a haplo-identical allogeneic transplant for another condition (acute leukemia, myelodysplastic syndrome), * a geno-identical or 10/10 matched unrelated allogeneic transplant, for myelofibrosis or for other condition (acute leukemia, myelodysplastic syndrome)
Interventions
OTHERBlood sampling
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and older * With one of the following conditions: * Acute leukemia (AL) * Myelofibrosis (MF) * Myelodysplastic syndrome (MDS) * Indicated for allogeneic hematopoietic stem cell (HSC) transplantation from: * a haploidentical donor with post-transplant cyclophosphamide OR * a geno-identical donor, without post-transplant cyclophosphamide OR * a pheno-identical donor, without post-transplant cyclophosphamide
Exclusion criteria
* Lymphoma * Non-malignant disease * Patient's refusal to participate in this study * Patient's refusal to have their data recorded in the EBMT registry * Transplant from an unrelated donor 9/10 * Person under legal guardianship or curatorship, or unable to give informed consent * Person subject to judicial protective measures, or deprived of liberty by a judicial or administrative decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GVHD panel 2 cytokines in haplo-identical transplantation | At day 7 | Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of toxicities | Up to 45 days after transplantation | CTCAE Grade \>1 |
| Cytokine level | Up to day 7 | Changes in cytokine levels before and after transplantation comparison according the hematologic condition and the type of allogeneic transplantation between Day -7 and Day 0, and between Day 0 and Day +7 |
| Non-relapse mortality | At 6 months | — |
| Occurrence of early acute GVHD | 45 days after transplantation | Occurrence of early acute GVHD ; comparison according the hematologic condition and the type of allogeneic transplantation |
| Overall survival | At 12 months | Overall survival; defined as the time from Day 0 to death from any cause ; comparison according the hematologic condition and the type of allogeneic transplantation |
| Cytokine profile | 7 days before allogeneic transplantation | Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation |
Contacts
CONTACTMarie Robin, MD PhD
CONTACTJérôme Lambert
Outcome results
None listed