Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
NCT ID: NCT00600938
Last Updated: 2014-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
197 participants
INTERVENTIONAL
2007-11-30
2013-03-31
Brief Summary
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The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart.
Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Deferasirox
20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
Core Study: Deferasirox
20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
Deferasirox
Deferasirox Placebo
50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
Core Study: Deferoxamine
50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
Deferoxamine
Extension: deferoxamine to deferasirox
"DFO to ICL" (patients who switched from DFO to deferasirox in extension)
Extension: deferoxamine to deferasirox
40 mg/kg deferasirox once daily administered 30 minutes before taking food.
Extension: deferasirox to deferoxamine
"ICL to DFO" (patients who switched from deferasirox to DFO in extension)
Extension: deferasirox to deferoxamine
DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,
Interventions
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Core Study: Deferasirox
20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
Core Study: Deferoxamine
50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
Extension: deferoxamine to deferasirox
40 mg/kg deferasirox once daily administered 30 minutes before taking food.
Extension: deferasirox to deferoxamine
DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,
Deferasirox
Deferoxamine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with cardiac iron as measured by a myocardial T2\* value that is ≥ 6ms but not ≥ 20 ms.
* Patients with a lifetime history of at least 50 units of red cell transfusions, and must be receiving at least ≥10 units/yr of red blood cells transfusions.
* Patients with a left ventricular ejection fraction (LVEF) ≥ 56 % as determined by cardiovascular magnetic resonance (CMR).
* Patients with liver iron content (LIC) value ≥ 3 mg Fe / g dw, as determined by liver MRI.
Exclusion Criteria
* Patients unable to undergo study assessments including MRI
* Patients participating in another clinical trial or receiving an investigational drug.
10 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Nanning, Guangxi, China
Novartis Investigative Site
Limassol, , Cyprus
Novartis Investigative Site
Al Mansurah, , Egypt
Novartis Investigative Site
Cairo, , Egypt
Novartis Investigative Site
Cagliari, CA, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Hazmiyeh, , Lebanon
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Adana, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Antalya, , Turkey (Türkiye)
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Dubai, Dubai, United Arab Emirates
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
Leeds, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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References
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Pennell DJ, Porter JB, Piga A, Lai YR, El-Beshlawy A, Elalfy M, Yesilipek A, Kilinc Y, Habr D, Musallam KM, Shen J, Aydinok Y; CORDELIA study investigators. Sustained improvements in myocardial T2* over 2 years in severely iron-overloaded patients with beta thalassemia major treated with deferasirox or deferoxamine. Am J Hematol. 2015 Feb;90(2):91-6. doi: 10.1002/ajh.23876. Epub 2014 Nov 19.
Pennell DJ, Porter JB, Piga A, Lai Y, El-Beshlawy A, Belhoul KM, Elalfy M, Yesilipek A, Kilinc Y, Lawniczek T, Habr D, Weisskopf M, Zhang Y, Aydinok Y; CORDELIA study investigators. A 1-year randomized controlled trial of deferasirox vs deferoxamine for myocardial iron removal in beta-thalassemia major (CORDELIA). Blood. 2014 Mar 6;123(10):1447-54. doi: 10.1182/blood-2013-04-497842. Epub 2014 Jan 2.
Other Identifiers
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2007-000766-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CICL670A2206
Identifier Type: -
Identifier Source: org_study_id
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