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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie Robin, MD PhD
- Phone Number: +33 01 42 49 47 60
- Email: marie.robin@aphp.fr
Study Contact Backup
- Name: Jérôme Lambert
- Phone Number: 0142499742
- Email: jerome.lambert@u-paris.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to day 7
|
|
Cytokine profile
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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
|
At 12 months
|
|
Non-relapse mortality
Time Frame: At 6 months
|
At 6 months
|
|
|
Non-relapse mortality
Time Frame: At 12 months
|
At 12 months
|
|
|
Incidence of toxicities
Time Frame: Up to 45 days after transplantation
|
CTCAE Grade >1
|
Up to 45 days after transplantation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hematologic Diseases
- Bone Marrow Diseases
- Myeloproliferative Disorders
- Hemic and Lymphatic Diseases
- Myelodysplastic Syndromes
- Primary Myelofibrosis
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- APHP260773
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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