Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML

NCT06267898 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 222

Last updated 2024-02-20

No results posted yet for this study

Summary

Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.

Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).

There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards.

Conditions

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY
  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • T. de Witte, MD · Radboud University Medical Center

  • E. Cremers · VUMC - VU University Medical Centre Amsterdam

  • N. Kröger, MD · Universitätsklinikum Hamburg-Eppendorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-01
Primary Completion
2015-01-29
Completion
2015-05-21

Countries

  • Belgium
  • Czechia
  • Germany

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267898 on ClinicalTrials.gov