An observational study in Myelofibrosis, Acute Leukemia and Myelodysplastic Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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 :
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 96 is below the median of 125 across 73 observational studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patient hospitalized for an allogeneic hematopoietic stem cell (HSC) transplantation for myelofibrosis, acute leukemia (AL), or myelodysplastic syndrome (MDS)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
With one of the following conditions:
Indicated for allogeneic hematopoietic stem cell (HSC) transplantation from:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with myelofibrosis receiving a haplo-identical allogeneic transplant
Other: Blood sampling
Patients with myelofibrosis receiving a geno- or pheno-identical allogeneic transplant
Other: Blood sampling
Patients with acute leukemia or myelodysplastic syndrome receiving a haplo-identical allogeneic transplant
Other: Blood sampling
Patients with acute leukemia or myelodysplastic syndrome a geno- or pheno-identical allogeneic transplant
Other: Blood sampling
Blood sampling at D-7, D0 and D+7 from allogeneic transplantation
GVHD panel 2 cytokines in haplo-identical transplantation
Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients
Time frame: At day 7
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
Time frame: Up to day 7
Cytokine profile
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Time frame: 7 days before allogeneic transplantation
Cytokine profile
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Time frame: the day of allogeneic transplantation
Cytokine profile
Peri-graft cytokine profile, comparison according the hematologic condition and the type of allogeneic transplantation
Time frame: 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
Time frame: 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
Time frame: At 12 months
Non-relapse mortality
Time frame: At 6 months
Non-relapse mortality
Time frame: At 12 months
Incidence of toxicities
CTCAE Grade \>1
Time frame: Up to 45 days after transplantation
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Apr 2028, 18 months later.
Of 23 observational studies under Primary Myelofibrosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 119. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris →