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Clinical Trials/EUCTR2006-006147-31-IT
EUCTR2006-006147-31-IT
Active, not recruiting
Not Applicable

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

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 sitesMay 4, 2007
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Conditionsow and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ow and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.
Sponsor
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 4, 2007
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO

Eligibility Criteria

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 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:

Exclusion Criteria

  • •?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

Outcomes

Primary Outcomes

Not specified

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