NCT01335035

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

March 30, 2011

Last Update Submit

April 27, 2012

Conditions

Iron Overload

Keywords

Iron metabolism,Allogenetic Hematopoietic Stem Cell Transplant,haematological diseases

Outcome Measures

Primary Outcomes (1)

  • Mean change in serum ferritin

    after 52 weeks of treatment with deferasirox

Secondary Outcomes (5)

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

    after 52 weeks of treatment with deferasirox

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

    after 52 weeks of treatment with deferasirox

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

    up to 52 weeks of study

  • Incidence of infections (bacterial, viral, or fungal)

    up to 52 weeks of study

  • Incidence of venous occlusive disease during the study

    up to 52 weeks of study

Study Arms (1)

ICL670

EXPERIMENTAL
Drug: deferasirox

Interventions

deferasiroxDRUG
Also known as: ICL670
ICL670

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients 18 years of age and older
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Andalucia, Spain

Location

Novartis Investigative Site

Asturias, Spain

Location

Novartis Investigative Site

Canarias, Spain

Location

Novartis Investigative Site

Castilla Y Leon, Spain

Location

Novartis Investigative Site

Cataluna, Spain

Location

Novartis Investigative Site

Comunidad Valenciana, Spain

Location

Novartis Investigative Site

Islas Baleares, Spain

Location

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigative Site

Murcia, Spain

Location

Related Publications (1)

  • Vallejo C, Batlle M, Vazquez L, Solano C, Sampol A, Duarte R, Hernandez D, Lopez J, Rovira M, Jimenez S, Valcarcel D, Belloch V, Jimenez M, Jarque I; Subcommittee of Non-Infectious Complications of the Grupo Espanol de Trasplante Hematopoyetico (GETH). Phase IV open-label study of the efficacy and safety of deferasirox after allogeneic stem cell transplantation. Haematologica. 2014 Oct;99(10):1632-7. doi: 10.3324/haematol.2014.105908. Epub 2014 Jul 4.

    PMID: 24997153DERIVED

MeSH Terms

Conditions

Iron Overload

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 13, 2011

Study Start

December 1, 2008

Primary Completion

May 1, 2011

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

ES(9)