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Combo Chelation Trial

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ClinicalTrials.gov Identifier: NCT00901199
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Elliott Vichinsky, UCSF Benioff Children's Hospital Oakland

Tracking Information
First Submitted Date  ICMJE May 12, 2009
First Posted Date  ICMJE May 13, 2009
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2009)
Monitoring kidney function with urine protein/creatine levels [ Time Frame: with transfusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combo Chelation Trial
Official Title  ICMJE Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Brief Summary This is a small pilot study looking at the safety of giving combination chelation with Exjade and Desferal to 15 patients. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thalassemia
  • Iron Overload
Intervention  ICMJE Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)
Study Arms  ICMJE
  • Child Cohort
    This is the cohort in the study for children ages 8-18 years old. All subjects in this arm must have Liver Iron by SQUID of between 5-15mg/g dry liver and have a documented endocrinopathy or cardiac finding (low T2* or decreased cardiac function). All subjects in this arm will receive 7 days per week of Exjade and 3-5 days per week of Desferal.
    Intervention: Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
  • Moderate Adult Cohort
    Adults in this arm will have moderate iron overload,defined as SQUID of 5-15mg/g dry weight. They will also have to have a documented endocrinopathy or cardiac finding (low T2*). All subjects in this cohort will receive 7 days per week of Exjade (20-30mg/kg) and Desferal (50mg/kg)3-5 days per week.
    Intervention: Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
  • Adults cohort with high iron overload
    Adults with high iron overload defined as over 15mg/g dry liver. No cardiac finding or endocrinopathy necessary. Subjects in this cohort will receive Exjade 20-30mg/kg 7 days per week and Desferal (50mg/kg)5-7 days per week.
    Intervention: Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
Publications * Lal A, Porter J, Sweeters N, Ng V, Evans P, Neumayr L, Kurio G, Harmatz P, Vichinsky E. Combined chelation therapy with deferasirox and deferoxamine in thalassemia. Blood Cells Mol Dis. 2013 Feb;50(2):99-104. doi: 10.1016/j.bcmd.2012.10.006. Epub 2012 Nov 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2013)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2009)
15
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Transfusion Dependent Thalassemia
  • If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
  • Older than 8 years

Exclusion Criteria:

  • Participating on another interventional clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00901199
Other Study ID Numbers  ICMJE CICL670AUS24T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elliott Vichinsky, UCSF Benioff Children's Hospital Oakland
Study Sponsor  ICMJE UCSF Benioff Children's Hospital Oakland
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account UCSF Benioff Children's Hospital Oakland
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP