MyelofibrosisCytokinegreffeNCT07805746
Peri-graft Cytokine Profile: Influence of Hematologic Disease and Donor Type
An observational study of Myelofibrosis and Acute Leukemia, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Acute Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Blood sampling
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient hospitalized for an allogeneic hematopoietic stem cell (HSC) transplantation for myelofibrosis, acute leukemia (AL), or myelodysplastic syndrome (MDS)
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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)
- Conditions
- Myelofibrosis, Acute Leukemia, Myelodysplastic Syndrome, Hematopoietic Stem Cell Transplant (HSCT)
- Being tested
- Blood sampling
- Keywords
- Peri-graft cytokine Profile, Influence of Hematologic Disease, Influence of Donor Type
- Medical subject headings
- Primary Myelofibrosis, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
| Study group | Role | What they receive |
|---|---|---|
| MF-Haplo | Patients with myelofibrosis receiving a haplo-identical allogeneic transplant Receives: Other: Blood sampling | |
| MF-10/10 | Patients with myelofibrosis receiving a geno- or pheno-identical allogeneic transplant Receives: Other: Blood sampling | |
| AL-haplo | Patients with acute leukemia or myelodysplastic syndrome receiving a haplo-identical allogeneic transplant Receives: Other: Blood sampling | |
| AL-10/10 | Patients with acute leukemia or myelodysplastic syndrome a geno- or pheno-identical allogeneic transplant Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD panel 2 cytokines in haplo-identical transplantation
Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients
Measured: At day 7
Secondary outcomes (9)
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
Measured: Up to day 7
Cytokine profile
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Measured: 7 days before allogeneic transplantation
Cytokine profile
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Measured: the day of allogeneic transplantation
Cytokine profile
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Measured: 7 days after allogeneic transplantation
Occurrence of early acute GVHD
Occurrence of early acute GVHD ; comparison according the hematologic condition and the type of allogeneic transplantation
Measured: 45 days after transplantation
Overall survival
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
Measured: At 12 months
Non-relapse mortality
Measured: At 6 months
Non-relapse mortality
Measured: At 12 months
Incidence of toxicities
CTCAE Grade >1
Measured: Up to 45 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805746
- Sponsor's protocol ID
- APHP260773
- Acronym
- Cytokinegreffe
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profil Cytokinique péri-greffe : Influence de l'hémopathie et du Type de Donneur
- ClinicalTrials.gov ID
- NCT07805746
- Acronym / sponsor ID
- Cytokinegreffe / APHP260773
- Conditions
- Myelofibrosis, Acute Leukemia, Myelodysplastic Syndrome, Hematopoietic Stem Cell Transplant (HSCT)
- Keywords
- Peri-graft cytokine Profile, Influence of Hematologic Disease, Influence of Donor Type
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MF-Haplo | – | Other: Blood samplingPatients with myelofibrosis receiving a haplo-identical allogeneic transplant |
| MF-10/10 | – | Other: Blood samplingPatients with myelofibrosis receiving a geno- or pheno-identical allogeneic transplant |
| AL-haplo | – | Other: Blood samplingPatients with acute leukemia or myelodysplastic syndrome receiving a haplo-identical allogeneic transplant |
| AL-10/10 | – | Other: Blood samplingPatients with acute leukemia or myelodysplastic syndrome a geno- or pheno-identical allogeneic transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient hospitalized for an allogeneic hematopoietic stem cell (HSC) transplantation for myelofibrosis, acute leukemia (AL), or myelodysplastic syndrome (MDS)
Key inclusion criteria (9 listed)
- Patients aged 18 years and older
- With one of the following conditions:
- Indicated for allogeneic hematopoietic stem cell (HSC) transplantation from:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling at D-7, D0 and D+7 from allogeneic transplantation | Other | AL-10/10, AL-haplo, MF-10/10, MF-Haplo |
Primary outcome
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
9 secondary outcomes
Cytokine level
Time frame: Up to day 7
Cytokine profile
Time frame: 7 days before allogeneic transplantation
Cytokine profile
Time frame: the day of allogeneic transplantation
Cytokine profile
Time frame: 7 days after allogeneic transplantation
Occurrence of early acute GVHD
Time frame: 45 days after transplantation
Overall survival
Time frame: At 12 months
Non-relapse mortality
Time frame: At 6 months
Non-relapse mortality
Time frame: At 12 months
Incidence of toxicities
Time frame: Up to 45 days after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis and Acute Leukemia, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Robin, MD PhD (01 42 49 47 60 ext. +33, marie.robin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD panel 2 cytokines in haplo-identical transplantation (time frame: At day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.