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NCT Number: NCT07028112

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Louis AP-HP

Paris, France

Location status: Recruiting

Location contact

Mathilde Ruggiu

CONTACT

[email protected]

+33142494760 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort

Other

Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.

Primary outcomes

  1. Event free survival

    Time frame: Up to 24 months

    From any hepatic complication ≥ 10 years after allogeneic HSCT

Secondary outcomes

  1. Overall free survival of any hepatic complication ≥ 10 years after HSCT

    Time frame: Up to 24 months

    Survival without hepatic complication

  2. Event free survival from liver fibrosis ≥ 10 years after HSCT

    Time frame: Up to 24 months

    Time from HSCT to first diagnosis of liver fibrosis by elastography (FibroScan® ≥ 8 kPa or shear wave ≥ 7 kPa).

    baseline to fibrosis diagnosis

  3. Event free survival for each specific hepatic complication ≥ 10 years after HSCT

    Time frame: Up to 24 months

    Separate analyses for cirrhosis, portal hypertension, hepatic GVHD, viral hepatitis, steatosis, etc

  4. Event free survival from iron overload ≥ 10 years after HSCT

    Time frame: Up to 24 months

    Time from HSCT to first diagnosis of iron overload

  5. Efficacy of curative treatments for iron overload in preventing hepatic complications

    Time frame: Up to 24 months

    International non-proprietary names, dates and doses of treatments received for iron overload ≥ 10 years after HSCT

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Mathilde Ruggiu, MD

CONTACT

[email protected]

142494760 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: AlloFer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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