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OpenTrials
Completed

NCT Number: NCT00481143

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

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.

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Key information

Conditions

Myelodysplastic Syndromes Anemia Anemia, Refractory Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases Transfusion Dependent Iron Overload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICL670/Deferasirox

Drug

Other names: ICL670

Primary outcomes

  1. To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox

    Time frame: 52 weeks

Secondary outcomes

  1. Safety and tolerability of deferasirox assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
First posted
Jun 1, 2007
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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