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Efficacy and Safety of Oral Deferasirox (20 mg/kg/Day) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload
This study is currently recruiting participants.
Verified by Novartis, April 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00654589
  Purpose

The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.


Condition Intervention Phase
Iron Overload
Drug: ICL670/Deferasirox
Phase IV

MedlinePlus related topics: Blood Transfusion and Donation
Drug Information available for: Deferasirox Ferritin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A One-Year, Open-Label, Single Arm, Multi-Center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox

Secondary Outcome Measures:
  • To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.

Estimated Enrollment: 75
Study Start Date: February 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Transfusional iron overload three to six months after HCT with no evidence of active inflammation
  2. History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
  3. Patients of either gender and age ≥ 18 years.
  4. Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraception , or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.

Exclusion criteria

  1. Non-transfusion related iron overload
  2. Active malignancy
  3. Known active viral hepatitis or known HIV positiveness
  4. Mean levels of alanine aminotransferase (ALT) > 5x ULN
  5. Treatment with any iron chelator after transplantation
  6. Uncontrolled systemic hypertension
  7. Serum creatinine > 1.5 ULN and/or serum creatinine clearance < 60 ml/min
  8. History of nephrotic syndrome.
  9. Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
  10. Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
  11. Pregnant or breast feeding patients.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654589

Contacts
Contact: Novartis Basel 41 61 324 1111

Locations
Germany
Universitätsklinikum Leipzig-AÖR Recruiting
Leipzig, Germany, 04103
Contact: H-.K. Al-Ali, M.D.     + 49-3 41- 97 -13 125     alah@medizin.uni-leipzig.de    
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Study ID Numbers: CICL670ADE02
Study First Received: April 2, 2008
Last Updated: April 7, 2008
ClinicalTrials.gov Identifier: NCT00654589  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:
Hematopoietic stem cell transplantation
HCT
iron overload
chelators
ICL670
deferasirox
serum ferritin
LIC
transfusional hemosiderosis
blood transfusions
adults
iron chelation
3-6 months after allogeneic hematopoietic stem cell transplantation

Study placed in the following topic categories:
Metabolic Diseases
Deferasirox
Hemosiderosis
Iron Metabolism Disorders
Iron Overload
Metabolic disorder
Iron

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009