Post Hematopoietic Stem Cell Transplantation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICL670

Oral dose of ICL670 at 10 mg/kg daily

Group Type EXPERIMENTAL

ICL670

Intervention Type DRUG

Oral dose of ICL670 at 10 mg/kg daily

Interventions

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ICL670

Oral dose of ICL670 at 10 mg/kg daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No