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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01335035
First received: March 30, 2011
Last updated: April 27, 2012
Last verified: April 2012

March 30, 2011
April 27, 2012
December 2008
May 2011   (final data collection date for primary outcome measure)
Mean change in serum ferritin [ Time Frame: after 52 weeks of treatment with deferasirox ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01335035 on ClinicalTrials.gov Archive Site
  • Mean change in the no. of sideroblasts, assessed by Perls staining [ Time Frame: after 52 weeks of treatment with deferasirox ] [ Designated as safety issue: No ]
  • Mean change in liver iron concentration (LIC), assessed by liver MRI. [ Time Frame: after 52 weeks of treatment with deferasirox ] [ Designated as safety issue: No ]
  • Incidence of chronic graft-versus-host disease ("limited" or "extensive", according to Shulman criteria) [ Time Frame: up to 52 weeks of study ] [ Designated as safety issue: Yes ]
  • Incidence of infections (bacterial, viral, or fungal) [ Time Frame: up to 52 weeks of study ] [ Designated as safety issue: Yes ]
  • Incidence of venous occlusive disease during the study [ Time Frame: up to 52 weeks of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload
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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Iron Overload
Drug: deferasirox
Other Name: ICL670
Experimental: ICL670
Intervention: Drug: deferasirox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
May 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01335035
CICL670AES04, EudraCT: 2008-003207-30
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP