- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07805746
Peri-graft Cytokine Profile: Influence of Hematologic Disease and Donor Type (Cytokinegreffe)
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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Marie Robin, MD PhD
- Telefoonnummer: +33 01 42 49 47 60
- E-mail: marie.robin@aphp.fr
Studie Contact Back-up
- Naam: Jérôme Lambert
- Telefoonnummer: 0142499742
- E-mail: jerome.lambert@u-paris.fr
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
GVHD panel 2 cytokines in haplo-identical transplantation
Tijdsspanne: At day 7
|
Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients
|
At day 7
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cytokine level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At 6 months
|
At 6 months
|
|
|
Non-relapse mortality
Tijdsspanne: At 12 months
|
At 12 months
|
|
|
Incidence of toxicities
Tijdsspanne: Up to 45 days after transplantation
|
CTCAE Grade >1
|
Up to 45 days after transplantation
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Hematologische ziekten
- Beenmergziekten
- Myeloproliferatieve aandoeningen
- Hemische en lymfatische ziekten
- Myelodysplastische syndromen
- Primaire myelofibrose
- Onderzoekstechnieken
- Exemplaarbehandeling
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Buren
- Chirurgische procedures, operatief
- Bloedspecimenverzameling
Andere studie-ID-nummers
- APHP260773
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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