CompletedNot Applicable

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

Belgium, Czechia, Germany222 participantsStarted 2009-11-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with MDS or CMML, according to FAB-criteria (RA, RARS, RAEB, RAEBt, CMML) or according to WHO-criteria (RA, RARS, RAEB-1, RAEB-2, RCMD, RCMD-RS, with isolated del(5q), MDS OR CMML-U) * Patients with transformed MDS or CMML to AML at time of transplant * Patients received myeloablative or RIC allo-HSCT as primary treatment * Diagnosis at time of transplant * Informed Consent and of legal age at the time of obtaining informed consent (18+) * ECOG performance status 0-2 Exclusion Criteria: * Patients with previous intensive antileukemic therapy (intensive chemotherapy and/or HSCT); previous treatment with immunomodulatory drugs (thalidomide, or lenalidomide) or hypomethylating agents (Vidaza, decitabine) is allowed * Patients with juvenile chronic myelomonocytic leukemia (jMML) * Patients with secondary or therapy-related AML and MDS or CMML after treatment with immunosuppressive or cytotoxic treatment for a nonmyeloid malignancy * Patients who received auto-HSCT * Candidates for cord blood HSCT or syngeneic HSCT * Inadequate renal function (ECC \<60 ml/min and/or creatinine \>2.5 times upper limit of normal value) * Inadequate hepatic function (transaminases \>2.5 times upper limit of normal value) * History of seizures * Pregnancy and women of child-bearing potential and not using adequate contraceptives * Uncontrolled hypertension

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

non-relapse mortality (treatment related mortality).

Timeframe: 2 years after HSCT

Trial details

NCT IDNCT06267898

SponsorEuropean Society for Blood and Marrow Transplantation

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2015-01-29

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