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NCT Number: NCT07805746

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Blood sampling at D-7, D0 and D+7 from allogeneic transplantation

Primary outcomes

  1. GVHD panel 2 cytokines in haplo-identical transplantation

    Time frame: At day 7

    Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients

Secondary outcomes

  1. Cytokine level

    Time frame: 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

  2. Cytokine profile

    Time frame: 7 days before allogeneic transplantation

    Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation

  3. Cytokine profile

    Time frame: the day of allogeneic transplantation

    Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation

  4. Cytokine profile

    Time frame: 7 days after allogeneic transplantation

    Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation

  5. Occurrence of early acute GVHD

    Time frame: 45 days after transplantation

    Occurrence of early acute GVHD ; comparison according the hematologic condition and the type of allogeneic transplantation

  6. Overall survival

    Time frame: 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

  7. Non-relapse mortality

    Time frame: At 6 months

  8. Non-relapse mortality

    Time frame: At 12 months

  9. Incidence of toxicities

    Time frame: Up to 45 days after transplantation

    CTCAE Grade >1

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert

CONTACT

[email protected]

0142499742

Marie Robin, MD PhD

CONTACT

[email protected]

01 42 49 47 60 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Cytokinegreffe

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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