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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00654589

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Iron Overload	Drug: Deferasirox	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: deferasirox	Drug: Deferasirox Other Names: ICL670

Arm

Intervention/Treatment

Experimental: deferasirox

Drug: Deferasirox

Other Names:

ICL670

Outcome Measures

Primary Outcome Measures

To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox [52 weeks]

Secondary Outcome Measures

To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study. [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Transfusional iron overload three to six months after HCT with no evidence of active inflammation
History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
Patients of either gender and age ≥ 18 years.
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:

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