Combo Chelation Trial

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Elliott Vichinsky, Children's Hospital & Research Center Oakland

ClinicalTrials.gov Identifier:

NCT00901199

First received: May 12, 2009

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Thalassemia Iron Overload	Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload

Resource links provided by NLM:

MedlinePlus related topics: Iron Thalassemia

Drug Information available for: Deferoxamine mesylate Deferasirox

U.S. FDA Resources

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:

Monitoring kidney function with urine protein/creatine levels [ Time Frame: with transfusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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)
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.	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)
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.	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)

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901199

Locations

United States, California
CHRCO
Oakland, California, United States, 94609

Sponsors and Collaborators

Children's Hospital & Research Center Oakland

More Information

No publications provided by Children's Hospital & Research Center Oakland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Elliott Vichinsky, Director, Hematology/Oncology, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:	NCT00901199 History of Changes
Other Study ID Numbers:	CICL670AUS24T
Study First Received:	May 12, 2009
Last Updated:	May 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital & Research Center Oakland:

Thalassemia
Chelation
Iron Overload
Thalassemia patients with Iron overload

Additional relevant MeSH terms:

Iron Chelating Agents
Chelating Agents
Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders

Metabolic Diseases
Deferoxamine
Deferasirox
Iron
Siderophores
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013

To Top