An open multicenter clinical trial to evaluate the safety, tolerability and efficacy of Deferasirox (ICL670) in patients affected by Myelodysplastic syndrome and transfusional chronic hemosiderosis. - GIMEMA MDS 0306
- Conditions
- ow and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome
- Registration Number
- EUCTR2006-006147-31-IT
- Lead Sponsor
- G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?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 Desferal after a day of wash out
?Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate).
?Availability of data concerning blood transfusions during the 12 weeks before screening
?Serum ferritin >= 1000 ?g/L at least twice (at least 2 week interval between the 2 analysis) during the year before the screening
?Life expectancy > 12 months
?Availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
?Diagnosis different from MDS (i.e. mielofibrosis)
?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 (including thalidomide, 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 Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the trial is to assess the safety and tolerability of Deferasirox in patients with Myelodysplastic syndrome and transfusion-induced hemosiderosis.;Secondary Objective: ?To evaluate the efficacy of Deferasirox as chelation therapy in patients with Myelodysplastic syndrome, in terms of serum ferritin reduction compared to baseline values<br><br><br><br>?To evaluate the impact of chelation therapy with Deferasirox on the requirements of blood transfusions in a group of patients who do not receive growth factors or chemotherapy<br><br><br><br>?Quality of life assessment<br><br><br><br>?Chelation therapy compliance;Primary end point(s): Toxicity grade incidence >2 according to the NCI-CTCAE 3.0
- Secondary Outcome Measures
Name Time Method