Impact of Iron Overload on the Incidence of Liver Complications in Long-Term Survivors (≥10 Years) of Allogeneic Hematopoietic Stem-Cell Transplantation. (AlloFer)

Impact de la Surcharge en Fer Sur l'Incidence Des Complications hépatiques Chez Les Patients allogreffés de Cellules Souches hématopoïétiques à Plus de 10 Ans de la Greffe

This single-center, non interventional cohort study investigates whether chronic iron overload influences the incidence of liver complications in adults who are at least 10 years beyond allogeneic hematopoietic stem cell transplantation (allo HSCT). Approximately 400-500 survivors transplanted at Hôpital Saint Louis between January 2004 and December 2014 will be evaluated. Transplant characteristics, prior iron overload therapy, and historical hepatic events will be collected through the Promise database. At the same time, the prospective visit will include laboratory panels and non invasive liver stiffness measurement by FibroScan or shear wave elastography. The study's primary objective is to assess the impact of iron overload on the incidence of hepatic complications in patients more than 10 years after an allogeneic hematopoietic stem cell transplantation. Secondary aims include describing the spectrum and frequency of hepatic complications, determining risk factors (including graft versus host disease, conditioning regimen, and comorbidities), and evaluating the long term effectiveness of previous iron reduction treatments (phlebotomy or chelation). Results will clarify whether monitoring and treating iron overload in long term allo HSCT survivors can prevent late hepatic morbidity.

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Iron Overload; Hemosiderosis; Hematopoietic Stem Cell Transplantation (HSCT)
• Intervention / Treatment: Other: Cohort

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Mathilde Ruggiu, MD; Phone Number: +33 142494760; Email: mathilde.ruggiu-goirand@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hôpital Saint Louis AP-HP
    • Contact: Mathilde Ruggiu; Phone Number: +33 +33142494760; Email: mathilde.ruggiu-goirand@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (>18 years) who received allo HSCT at Hôpital Saint Louis (2004/01/01 and 2014/12/31) and are alive and attending annual follow up ≥10 years post transplant.

Description

Inclusion Criteria:

• Age ≥ 18 years at enrollment
• Allogeneic HSCT performed at Hôpital Saint Louis between 2004/01/01 and 2014/12/31
• Alive and attending routine annual follow up within the two years of the study
• Having given his non-opposition to study after understand overall aims
• With health insurance coverage
• Follow up consultation at Saint-Louis Hospital

Exclusion Criteria:

• Patient under legal protection (protection of the court, or in curatorship or guardianship).

not in relapse of the hematological disease at the time of inclusion.

• Patients under 45 Kg

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AlloFer cohort; Adults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up	Other: Cohort; Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event free survival	From any hepatic complication ≥ 10 years after allogeneic HSCT	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall free survival of any hepatic complication ≥ 10 years after HSCT	Survival without hepatic complication	Up to 24 months
Event free survival from liver fibrosis ≥ 10 years after HSCT	Time from HSCT to first diagnosis of liver fibrosis by elastography (FibroScan® ≥ 8 kPa or shear wave ≥ 7 kPa). baseline to fibrosis diagnosis	Up to 24 months
Event free survival for each specific hepatic complication ≥ 10 years after HSCT	Separate analyses for cirrhosis, portal hypertension, hepatic GVHD, viral hepatitis, steatosis, etc	Up to 24 months
Event free survival from iron overload ≥ 10 years after HSCT	Time from HSCT to first diagnosis of iron overload	Up to 24 months
Efficacy of curative treatments for iron overload in preventing hepatic complications	International non-proprietary names, dates and doses of treatments received for iron overload ≥ 10 years after HSCT	Up to 24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: June 11, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Elastography; Liver fibrosis; Iron overload; graft-versus-host disease; Long-term complications; Allogeneic hematopoietic stem-cell transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Immune System Diseases; Digestive System Diseases; Iron Metabolism Disorders; Fibrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Liver Diseases; Liver Cirrhosis; Graft vs Host Disease; Iron Overload; Hemosiderosis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Studies; Epidemiologic Study Characteristics; Cohort Studies
• Other Study ID Numbers: APH250402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No