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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and older

Acute leukemia (AL)

Myelofibrosis (MF)

Myelodysplastic syndrome (MDS)

Disqualifiers

Lymphoma

Non-malignant disease

Patient's refusal to participate in this study

Patient's refusal to have their data recorded in the EBMT registry

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Other intervention

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

Treatment groups

96 Participants
are divided into 4 treatment groups
Group A: MF-Haplo1 intervention
Group B: MF-10/101 intervention
Group C: AL-haplo1 intervention
Group D: AL-10/101 intervention

Trial outcomes

Primary outcomes

1

GVHD panel 2 cytokines in haplo-identical transplantation

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

Time frame
At day 7

Secondary outcomes

1

Cytokine level

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

Time frame
Up to day 7
2

Cytokine profile

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

Time frame
7 days before allogeneic transplantation
3

Cytokine profile

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

Time frame
the day of allogeneic transplantation
4

Cytokine profile

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

Time frame
7 days after allogeneic transplantation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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