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Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00564941
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Beta-Thalassemia Drug: deferasirox Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 309 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
Study Start Date : December 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Deferasirox

Arms and Interventions
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Arm Intervention/treatment
Experimental: Deferasirox Drug: deferasirox
Other Name: ICL670


Outcome Measures
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Primary Outcome Measures :
  1. This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload [ Time Frame: monthly during the therapy and at the end of the treatment (aftr 9 months therapy) ]

Secondary Outcome Measures :
  1. patient's compliance during the study assessed by the number of the unused tablets returned by the patient safety assessed by patient laboratory data, adverse events, serious adverse events [ Time Frame: during the treatment (9 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • In- or outpatients with myelodysplasia / with risk of low or intermedier-1 according to the International Prognostic Scoring System (IPSS) confirmed by bone marrow evaluation within 3 month/ or beta thalassaemia major patients, who have chronic iron overload, as a consequence of frequent blood transfusion
  • Serum ferritin> 1800 µg/L
  • Age: 18-80 years
  • men and women
  • Chronic iron overload caused by at least 30 units and maximum 100 units of blood of packed red blood cells
  • Deferoxamin therapy is contraindicated or inadequate or unable to use in the recommended dose due to intolerability or other reason
  • Eastern Cooperative Oncology Group (ECOG) performance status score between 0-2
  • written informed consent

Exclusion criteria:

  • beta thalassaemia minor,
  • haemosiderosis caused by other than chronic transfusional iron overload,
  • patients with impaired renal function (Creatinin clearance< 60 ml/ min),
  • pregnancy,
  • lactation,
  • patient of childbearing potential unwilling to use contraceptive precautions
  • known hypersensitivity to deferasirox or any ingredients,
  • impaired hepatic function (SGOT,SGPT 5x above UNL).
  • Patients severely ill due to underlying disease progression or other severe concomitant disease.
  • Patients with poor prognosis of karyotype
  • patients with malabsorption caused by inflammatory bowel disease, gastrectomy, pancreatitis or other medical condition
  • History of nephrotic syndrome
  • Significant proteinuria
  • Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
  • Patients with positive test to HIV

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564941


Locations
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Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Debrecen, Hungary
Novartis Investigative Site
Pecs, Hungary
Novartis Investigative Site
Szeged, Hungary
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00564941    
Other Study ID Numbers: CICL670AHU02
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Myelodysplastic Syndromes
beta-Thalassemia
Iron Overload
Iron Chelating Agents
deferasirox
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Thalassemia
beta-Thalassemia
Iron Overload
Syndrome
Disease
Pathologic Processes
Anemia
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
 Neoplasms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action