- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Marie Robin, MD PhD
- Telefonnummer: +33 01 42 49 47 60
- E-post: marie.robin@aphp.fr
Studera Kontakt Backup
- Namn: Jérôme Lambert
- Telefonnummer: 0142499742
- E-post: jerome.lambert@u-paris.fr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
GVHD panel 2 cytokines in haplo-identical transplantation
Tidsram: At day 7
|
Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients
|
At day 7
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cytokine level
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At 6 months
|
At 6 months
|
|
|
Non-relapse mortality
Tidsram: At 12 months
|
At 12 months
|
|
|
Incidence of toxicities
Tidsram: Up to 45 days after transplantation
|
CTCAE Grade >1
|
Up to 45 days after transplantation
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hematologiska sjukdomar
- Benmärgssjukdomar
- Myeloproliferativa störningar
- Hemiska och lymfsjukdomar
- Myelodysplastiska syndrom
- Primär myelofibros
- Undersökningstekniker
- Provhantering
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Punktering
- Kirurgiska ingrepp, operativ
- Blodprovsamling
Andra studie-ID-nummer
- APHP260773
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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