Peri-graft Cytokine Profile: Influence of Hematologic Disease and Donor Type

NCT07805746 | Not Yet Recruiting

• 1 other identifier: APHP260773
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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, 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)

Conditions

Myelofibrosis; Acute Leukemia; Myelodysplastic Syndrome; Hematopoietic Stem Cell Transplant (HSCT)

Keywords

Peri-graft cytokine Profile; Influence of Hematologic Disease; Influence of Donor Type

Outcome Measures

Primary Outcomes (1)

• GVHD panel 2 cytokines in haplo-identical transplantation

  Comparison of ST2 and REG3α dosages between MF-haplo and AL-haplo patients

  At day 7

Secondary Outcomes (9)

• Cytokine level

  Up to day 7

• Cytokine profile

  7 days before allogeneic transplantation

• Cytokine profile

  the day of allogeneic transplantation

• Cytokine profile

  7 days after allogeneic transplantation

• Occurrence of early acute GVHD

  45 days after transplantation

Study Arms (4)

MF-Haplo

Patients with myelofibrosis receiving a haplo-identical allogeneic transplant

Other: Blood sampling

MF-10/10

Patients with myelofibrosis receiving a geno- or pheno-identical allogeneic transplant

Other: Blood sampling

AL-haplo

Patients with acute leukemia or myelodysplastic syndrome receiving a haplo-identical allogeneic transplant

Other: Blood sampling

AL-10/10

Patients with acute leukemia or myelodysplastic syndrome a geno- or pheno-identical allogeneic transplant

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling at D-7, D0 and D+7 from allogeneic transplantation

AL-10/10; AL-haplo; MF-10/10; MF-Haplo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient hospitalized for an allogeneic hematopoietic stem cell (HSC) transplantation for myelofibrosis, acute leukemia (AL), or myelodysplastic syndrome (MDS)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Primary Myelofibrosis; Myelodysplastic Syndromes

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Marie Robin, MD PhD

CONTACT

01 42 49 47 60; marie.robin@aphp.fr

Jérôme Lambert

CONTACT

0142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09