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

1. september 2026 oppdatert av: Assistance Publique - Hôpitaux de Paris

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)

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Antatt)

96

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patient hospitalized for an allogeneic hematopoietic stem cell (HSC) transplantation for myelofibrosis, acute leukemia (AL), or myelodysplastic syndrome (MDS)

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
MF-Haplo
Patients with myelofibrosis receiving a haplo-identical allogeneic transplant
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
MF-10/10
Patients with myelofibrosis receiving a geno- or pheno-identical allogeneic transplant
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
AL-haplo
Patients with acute leukemia or myelodysplastic syndrome receiving a haplo-identical allogeneic transplant
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
AL-10/10
Patients with acute leukemia or myelodysplastic syndrome a geno- or pheno-identical allogeneic transplant
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
GVHD panel 2 cytokines in haplo-identical transplantation
Tidsramme: At day 7
Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients
At day 7

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cytokine level
Tidsramme: 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
Up to day 7
Cytokine profile
Tidsramme: 7 days before allogeneic transplantation
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
7 days before allogeneic transplantation
Cytokine profile
Tidsramme: the day of allogeneic transplantation
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
the day of allogeneic transplantation
Cytokine profile
Tidsramme: 7 days after allogeneic transplantation
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
7 days after allogeneic transplantation
Occurrence of early acute GVHD
Tidsramme: 45 days after transplantation
Occurrence of early acute GVHD ; comparison according the hematologic condition and the type of allogeneic transplantation
45 days after transplantation
Overall survival
Tidsramme: 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
At 12 months
Non-relapse mortality
Tidsramme: At 6 months
At 6 months
Non-relapse mortality
Tidsramme: At 12 months
At 12 months
Incidence of toxicities
Tidsramme: Up to 45 days after transplantation
CTCAE Grade >1
Up to 45 days after transplantation

Samarbeidspartnere og etterforskere

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Antatt)

15. september 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. april 2029

Datoer for studieregistrering

Først innsendt

1. september 2026

Først innsendt som oppfylte QC-kriteriene

1. september 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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