Blood sampling
OtherBlood sampling at D-7, D0 and D+7 from allogeneic transplantation
NCT Number: NCT07805746
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)
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
Time frame: At day 7
Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients
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
Time frame: 7 days before allogeneic transplantation
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Time frame: the day of allogeneic transplantation
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Time frame: 7 days after allogeneic transplantation
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Time frame: 45 days after transplantation
Occurrence of early acute GVHD ; comparison according the hematologic condition and the type of allogeneic transplantation
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
Time frame: At 6 months
Time frame: At 12 months
Time frame: Up to 45 days after transplantation
CTCAE Grade >1
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Profil Cytokinique péri-greffe : Influence de l'hémopathie et du Type de Donneur
Acronym: Cytokinegreffe
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