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Completed

NCT Number: NCT01335035

Open-Label Single-Arm Pilot Study 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.

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Key information

Conditions

Iron Overload Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Andalucia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deferasirox

Drug

Other names: ICL670

Primary outcomes

  1. Mean change in serum ferritin

    Time frame: after 52 weeks of treatment with deferasirox

Secondary outcomes

  1. Mean change in the no. of sideroblasts, assessed by Perls staining

    Time frame: after 52 weeks of treatment with deferasirox

  2. Mean change in liver iron concentration (LIC), assessed by liver MRI.

    Time frame: after 52 weeks of treatment with deferasirox

  3. Incidence of chronic graft-versus-host disease ("limited" or "extensive", according to Shulman criteria)

    Time frame: up to 52 weeks of study

  4. Incidence of infections (bacterial, viral, or fungal)

    Time frame: up to 52 weeks of study

  5. Incidence of venous occlusive disease during the study

    Time frame: up to 52 weeks of study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
First posted
Apr 13, 2011
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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