Iron OverloadAlloFerNCT07028112
Impact of Iron Overload on the Incidence of Liver Complications in Long-Term Survivors (≥10 Years) of Allogeneic Hematopoietic Stem-Cell Transplantation.
An observational study of Iron Overload and Hemosiderosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Overload, Hemosiderosis, Liver Diseases
- What is being tested?
- Cohort
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2025to 20 Aug 2027
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Louis AP-HP
Paris
Mathilde Ruggiu, +33142494760 ext. +33, mathilde.ruggiu-goirand@aphp.fr
About this study
Official 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
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.
- Conditions
- Iron Overload, Hemosiderosis, Liver Diseases, Hematopoietic Stem Cell Transplantation (HSCT)
- Being tested
- Cohort
- Keywords
- Iron overload, Liver fibrosis, Elastography, Long-term complications, Allogeneic hematopoietic stem-cell transplantation, graft-versus-host disease
- Medical subject headings
- Iron Overload, Hemosiderosis, Liver Diseases, Liver Cirrhosis, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortOther
Participants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records.
| Study group | Role | What they receive |
|---|---|---|
| AlloFer cohort | Adults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up Receives: Other: Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
From any hepatic complication ≥ 10 years after allogeneic HSCT
Measured: Up to 24 months
Secondary outcomes (5)
Overall free survival of any hepatic complication ≥ 10 years after HSCT
Survival without hepatic complication
Measured: 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
Measured: 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
Measured: Up to 24 months
Event free survival from iron overload ≥ 10 years after HSCT
Time from HSCT to first diagnosis of iron overload
Measured: 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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start20 Aug 2025
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies 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
- 500 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
- NCT07028112
- Sponsor's protocol ID
- APH250402
- Acronym
- AlloFer
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2025
- Last updated
- 27 Apr 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07028112
- Acronym / sponsor ID
- AlloFer / APH250402
- Conditions
- Iron Overload, Hemosiderosis, Liver Diseases, Hematopoietic Stem Cell Transplantation (HSCT)
- Keywords
- Iron overload, Liver fibrosis, Elastography, Long-term complications, Allogeneic hematopoietic stem-cell transplantation, graft-versus-host disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 19 Jun 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AlloFer cohort | – | Other: CohortAdults transplanted at Hôpital Saint Louis (2004-2014) and alive ≥10 years post allo HSCT; evaluated once during routine annual follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| CohortParticipants undergo one routine visit blood draw and non invasive liver stiffness measurement. Retrospective data are abstracted from medical records. | Other | AlloFer cohort |
Primary outcome
Event free survival
Time frame: Up to 24 months
From any hepatic complication ≥ 10 years after allogeneic HSCT
5 secondary outcomes
Overall free survival of any hepatic complication ≥ 10 years after HSCT
Time frame: Up to 24 months
Event free survival from liver fibrosis ≥ 10 years after HSCT
Time frame: Up to 24 months
Event free survival for each specific hepatic complication ≥ 10 years after HSCT
Time frame: Up to 24 months
Event free survival from iron overload ≥ 10 years after HSCT
Time frame: Up to 24 months
Efficacy of curative treatments for iron overload in preventing hepatic complications
Time frame: Up to 24 months
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 27 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Overload and Hemosiderosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mathilde Ruggiu, MD (142494760 ext. +33, mathilde.ruggiu-goirand@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: Up to 24 months). 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 27 Apr 2026.