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

April 27, 2012 updated by: Novartis Pharmaceuticals

Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Andalucia, Spain
        • Novartis Investigative Site
      • Asturias, Spain
        • Novartis Investigative Site
      • Canarias, Spain
        • Novartis Investigative Site
      • Castilla y Leon, Spain
        • Novartis Investigative Site
      • Cataluna, Spain
        • Novartis Investigative Site
      • Comunidad Valenciana, Spain
        • Novartis Investigative Site
      • Islas baleares, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Murcia, Spain
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Other protocol-defined inclusion/exclusion criteria may app

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICL670
Drug: deferasirox
Other Names:
  • ICL670

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in serum ferritin
Time Frame: after 52 weeks of treatment with deferasirox
after 52 weeks of treatment with deferasirox

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in the no. of sideroblasts, assessed by Perls staining
Time Frame: after 52 weeks of treatment with deferasirox
after 52 weeks of treatment with deferasirox
Mean change in liver iron concentration (LIC), assessed by liver MRI.
Time Frame: after 52 weeks of treatment with deferasirox
after 52 weeks of treatment with deferasirox
Incidence of chronic graft-versus-host disease ("limited" or "extensive", according to Shulman criteria)
Time Frame: up to 52 weeks of study
up to 52 weeks of study
Incidence of infections (bacterial, viral, or fungal)
Time Frame: up to 52 weeks of study
up to 52 weeks of study
Incidence of venous occlusive disease during the study
Time Frame: up to 52 weeks of study
up to 52 weeks of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670AES04
  • EudraCT: 2008-003207-30 (Registry Identifier: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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