Phase
Condition
Iron Overload (Hemachromatosis)
Myelodysplastic Syndromes (Mds)
White Cell Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients, both males and females, with low and intermediate I risk (IPSS score)Myelodysplastic syndrome and transfusion-induced hemosiderosis.
Age >=18 years
Patients who never received chelation therapy or who received a therapy with Desferalafter a day of wash out
Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of redcells concentrate).
Availability of data concerning blood transfusions during the 12 weeks beforescreening
Serum ferritin >= 1000 µg/L at least twice (at least 2 week interval between the 2analysis) during the year before the screening
Life expectancy > 12 months
Availability of at least 3 complete blood counts (before transfusions) during the 12weeks before the screening
Exclusion
Exclusion Criteria:
Diagnosis different from MDS (i.e. myelofibrosis)
Severe renal impairment (creatinine clearance < 60 ml/min)
ALT/AST > 500 U/L
Active B and/or C hepatitis
Patients treated during the past 4 weeks with experimental drugs for MDS (includingthalidomide, azacitidine, arsenic trioxide). These patients become eligible after a "wash out" of at least 4 weeks
Concomitant treatment with another iron-chelating agent
Study Design
Study Description
Connect with a study center
SOC EMATOLOGIA ASO SS Antonio e Biagio
Alessandria,
ItalySite Not Available
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna,
ItalySite Not Available
CTMO-Ematologia Ospedale Binaghi
Cagliari,
ItalySite Not Available
Ospedale "A. Businco"
Cagliari,
ItalySite Not Available
Oncoematologia "A.O.R.N. S'Anna e S.Sebastiano"
Caserta,
ItalySite Not Available
US Dipartimentale Centro per le Malattie del Sangue
Castelfranco Veneto,
ItalySite Not Available
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania,
ItalySite Not Available
Policlinico di Careggi, Università delgi studi di Firenze
Firenze,
ItalySite Not Available
Clinica Ematologica - Università degli Studi
Genova,
ItalySite Not Available
Divisione di Ematologia e TMO - Ospedale "A. Cardarelli "- Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli,
ItalySite Not Available
Clinica Ematol Università di Perugia, Policlinico Monteluce
Perugia,
ItalySite Not Available
Ematologia- Università degli Studi "La Sapienza"
Roma,
ItalySite Not Available
Università Cattolica del Sacro Cuore
Roma,
ItalySite Not Available
Università degli Studi di Tor Vergata
Roma,
ItalySite Not Available
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo,
ItalySite Not Available
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena,
ItalySite Not Available
Ospedale Civile SS. Giovanni e Paolo
Venezia,
ItalySite Not Available
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