Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT).

The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving \> 20 RBC concentrates) after allogeneic HSCT.

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Detailed Description

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Conditions

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Iron Overload

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

Group Type EXPERIMENTAL

deferasirox

Intervention Type DRUG

Interventions

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deferasirox

Intervention Type DRUG

Other Intervention Names

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ICL670

Eligibility Criteria

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Inclusion Criteria

* Male or female patients 18 years of age and older
* Patients to undergo allogeneic HSCT between 6 and 18 months prior to inclusion.
* Patients with screening ANC \> 1000/mm3 and ferritin values ≥ 1000 ng/mL (ferritin values must be measured in two measurements at one-week intervals).
* Patients receiving at least 20 RBC concentrate units or 100mL/kg RBC during their lives.
* Patients giving their informed consent (prior to performing any study procedure)

Exclusion Criteria

* Haemosiderosis not related to transfusion.
* Patients with concomitant active malignancy.
* Active known viral hepatitis or known HIV-positive.
* Mean levels of alanine aminotransferase (ALT) \> 5x ULN
* Treatment with any iron chelating agent after allogeneic HSCT.
* Uncontrolled hypertension.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No