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

NCT07805746 — Not yet recruiting, 96 participants, Assistance Publique - Hôpitaux de Paris

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

Registry	NCT07805746, acronym Cytokinegreffe
Status	Not yet recruiting
Study type	Observational
Enrollment	96 (Estimated)
Sponsor	Assistance Publique - Hôpitaux de Paris (Other)
Conditions	Myelofibrosis, Acute Leukemia, Myelodysplastic Syndrome, Hematopoietic Stem Cell Transplant (HSCT)
Interventions	Blood sampling (Other)
Dates	start 2026-09-15 (estimated), primary completion 2028-04-01 (estimated), completion 2029-04-01 (estimated), first posted 2026-09-04, last updated 2026-09-04

-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)

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+Arms and interventions

Arm	Interventions	Description
MF-Haplo	Other: Blood sampling	Patients with myelofibrosis receiving a haplo-identical allogeneic transplant
MF-10/10	Other: Blood sampling	Patients with myelofibrosis receiving a geno- or pheno-identical allogeneic transplant
AL-haplo	Other: Blood sampling	Patients with acute leukemia or myelodysplastic syndrome receiving a haplo-identical allogeneic transplant
AL-10/10	Other: Blood sampling	Patients with acute leukemia or myelodysplastic syndrome a geno- or pheno-identical allogeneic transplant

Blood sampling (Other): Blood sampling at D-7, D0 and D+7 from allogeneic transplantation

+Outcome measures

Primary outcomes

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 outcomes

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
Cytokine profile [7 days before allogeneic transplantation]: Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Cytokine profile [the day of allogeneic transplantation]: Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Cytokine profile [7 days after allogeneic transplantation]: Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
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
Non-relapse mortality [At 6 months]
Non-relapse mortality [At 12 months]
Incidence of toxicities [Up to 45 days after transplantation]: CTCAE Grade >1

+Eligibility

Sex: All, ages: 18 Years to any

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