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 range18 Years

SexALL

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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

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