Peri-graft Cytokine Profile: Influence of Hematologic Disease and Donor Type

Profil Cytokinique péri-greffe : Influence de l'hémopathie et du Type de Donneur

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)

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