Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
NCT ID: NCT00110266
Last Updated: 2021-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2005-07-25
2008-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICL670
Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS
Deferasirox
20 mg/kg/day over one year in patients with MDS
Interventions
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Deferasirox
20 mg/kg/day over one year in patients with MDS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO).
* Age greater than or equal to 18 years
* Availability of transfusion records for the 12 weeks prior to registration
* A lifetime minimum of 30 previous packed red blood cell transfusions
* Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration
* Serum Ferritin:
For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year.
Serum ferritin ≥ 1000 ng/mL at screening via the central lab.
* Life expectancy ≥ 6 months
* Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
* Able to provide written informed consent
Exclusion Criteria
* Alanine aminotransferase (ALT) \> 500 U/L during screening
* Clinical or laboratory evidence of active Hepatitis B or C
* Urinary protein/creatinine ratio \> 0.5 mg/mg
* History of HIV positive test result (ELISA or Western blot)
* Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2
* Patients with uncontrolled systemic hypertension
* Unstable cardiac disease not controlled by standard medical therapy
* Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
* Pregnancy or breast feeding
* Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
* History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
18 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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Univ of Alabama Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
Bay Area Cancer Research Group
Concord, California, United States
City of Hope National Medical Center
Duarte, California, United States
Cedars-Sinai Medical Center, UCLA School of Medicine
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
UCSF
San Francisco, California, United States
UCSF
San Francisco, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Novartis Investigative Site
Chicago, Illinois, United States
University of Chicago Hospital
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky College of Medicine, Markey Cancer Center
Lexington, Kentucky, United States
Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital
Alexandria, Louisiana, United States
St. Agnes HealthCare
Baltimore, Maryland, United States
Rush Cancer Institute Univ. of Massachussets Medical Center
Worcester, Massachusetts, United States
Novartis Investigative Site
Southfield, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Center for Cancer Care & Research (TCCCR)
St Louis, Missouri, United States
Oncology Hematology West, PC
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Cancer Center at Hackensack University
Hackensack, New Jersey, United States
NMOHC
Albuquerque, New Mexico, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Rochester General Hospital/Lipson Cancer and Blood Center
Rochester, New York, United States
Cancer Care of WNC
Asheville, North Carolina, United States
Wake Forest UniversitComprehensive Cancer Center
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Novartis Investigative Site
Portland, Oregon, United States
Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital Cancer Institute
Pittsburgh, Pennsylvania, United States
The West Cancer Clinic
Memphis, Tennessee, United States
Novartis Investigative site
Nashville, Tennessee, United States
Baylor/The Methodist Hospital
Houston, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Arlington Fairfax Hematology Oncology PC
Arlington, Virginia, United States
Novartis Investigative Site
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Countries
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References
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List AF, Baer MR, Steensma DP, Raza A, Esposito J, Martinez-Lopez N, Paley C, Feigert J, Besa E. Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome. J Clin Oncol. 2012 Jun 10;30(17):2134-9. doi: 10.1200/JCO.2010.34.1222. Epub 2012 Apr 30.
Related Links
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Results for CICL670AUS03 from the Novartis Clinical Trials website
Publication (Embasse # 2012421150)
Publication (Embasse # 2012421150)
Other Identifiers
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CICL670AUS03
Identifier Type: -
Identifier Source: org_study_id
NCT00343837
Identifier Type: -
Identifier Source: nct_alias
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