Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload

Iron Overload Clinical Trial

Official title:

A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/d) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654589
• Other study ID #: CICL670ADE02
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2008
• Last updated: November 16, 2016
• Start date: February 2008
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Iron Overload

Intervention

Drug:
• Deferasirox

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Jaekel N, Lieder K, Albrecht S, Leismann O, Hubert K, Bug G, Kröger N, Platzbecker U, Stadler M, de Haas K, Altamura S, Muckenthaler MU, Niederwieser D, Al-Ali HK. Efficacy and safety of deferasirox in non-thalassemic patients with elevated ferritin level — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox		52 weeks	No
Secondary	To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.		52 weeks	No

External Links

•   CICL670ADE02 Results at Novartis Clinical Trials Results Website