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

Novartis

Status and phase: Completed; Phase 4

Conditions: Iron Overload

Treatments: Drug: Deferasirox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654589

CICL670ADE02

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

deferasirox

Experimental group

Treatment:

Drug: Deferasirox