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Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481143
First Posted: June 1, 2007
Last Update Posted: May 31, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose

The purpose of this study is to investigate the effects of iron chelation using deferasirox in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS patients who show signs of iron overload due to repeated blood transfusions.

This trial is not recruiting patients in the United States.


Condition Intervention Phase
Myelodysplastic Syndromes Transfusion Dependent Iron Overload Drug: ICL670/Deferasirox Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 in Patients Diagnosed With Low and INT-1 Risk Myelodysplastic Syndrome (MDS) and Transfusion-dependent Iron Overload

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Safety and tolerability of deferasirox assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 52 weeks ]

Enrollment: 63
Study Start Date: May 2007
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deferasirox Drug: ICL670/Deferasirox
Other Name: ICL670

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MDS patients presenting with low or intermediate-1 IPSS risk and transfusional iron overload
  • Patients of either gender and age ≥ 18 years
  • History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs)
  • Patients can be either naïve to iron chelation or have had prior treatment with deferoxamine (DFO) or deferiprone (L1)
  • Females of childbearing potential must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.

Exclusion Criteria:

  • Non-transfusion related iron overload
  • Treatment with deferasirox (ICL670) before study start
  • Patients with a concomitant malignant disease
  • Patients with out of range lab values
  • History of nephrotic syndrome
  • Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
  • Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
  • Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days
  • Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
  • Patients with active uncontrolled infectious disease
  • Pregnancy or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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): NCT00481143


Locations
Germany
Novartis Investigative Site
Berlin, Germany, 12200
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00481143     History of Changes
Other Study ID Numbers: CICL670ADE03
First Submitted: May 31, 2007
First Posted: June 1, 2007
Last Update Posted: May 31, 2017
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Myelodysplastic Syndrome
MDS
iron overload
chelation
chelators
ICL670
Deferasirox
serum ferritin
LIC
transfusional hemosiderosis
Refractory Anemia
RA
Refractory Anemia with Ringed Sideroblasts
RARS
blood transfusions
Mydelodysplastic Syndrome(s)

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Iron Overload
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action