Post Hematopoietic Stem Cell Transplantation

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a prospective, single-arm, multicenter, national, phase II clinical study. The purpose of this Phase II study was to examine the safety and efficacy of deferasirox to decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia major.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Deferasirox

Criteria

Inclusion Criteria

• Patients who had hematopoietic stem cell transplantation (HSCT) for beta-thalassemia major

• hematopoietic stem cell transplantation (HSCT) was performed minimum 6 months and maximum 2 years ago

• The washout period after the immunosuppressive therapy should be at least 3 months.

• Signifacant IOL should be present including:

A. Serum ferritin >1000 μg/L or B. cardiac MRI <20 ms or C. liver iron concentration ≥ 5 mg/g dry weight measured by R2* MRI

Exclusion Criteria

• Patients who had any contraindication for treatment with deferasirox according to the prescribing information

•Patients who depended on transfusion

• Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)

• Patients who were experiencing severe complication of HSCT e.g. acute Graft-versus host disease (GVHD)

• Significant proteinuria / Increase in serum creatinine