NCT00654589

Brief Summary

The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

3.9 years

First QC Date

April 2, 2008

Last Update Submit

November 16, 2016

Conditions

Iron Overload

Keywords

Hematopoietic stem cell transplantationHCTiron overloadchelatorsICL670deferasiroxserum ferritinLICtransfusional hemosiderosisblood transfusionsadultsiron chelation3-6 monthsallogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox

    52 weeks

Secondary Outcomes (1)

  • To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.

    52 weeks

Study Arms (1)

deferasirox

EXPERIMENTAL
Drug: Deferasirox

Interventions

DeferasiroxDRUG
Also known as: ICL670
deferasirox

Eligibility Criteria

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

You may qualify if:

  • Transfusional iron overload three to six months after HCT with no evidence of active inflammation
  • History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
  • Patients of either gender and age ≥ 18 years.
  • Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraception , or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.

You may not qualify if:

  • Non-transfusion related iron overload
  • Active malignancy
  • Known active viral hepatitis or known HIV positiveness
  • Mean levels of alanine aminotransferase (ALT) \> 5x ULN
  • Treatment with any iron chelator after transplantation
  • Uncontrolled systemic hypertension
  • Serum creatinine \> 1.5 ULN and/or serum creatinine clearance \< 60 ml/min
  • History of nephrotic syndrome.
  • Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
  • Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
  • Pregnant or breast feeding patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Leipzig, Germany

Location

Related Publications (1)

  • Jaekel N, Lieder K, Albrecht S, Leismann O, Hubert K, Bug G, Kroger N, Platzbecker U, Stadler M, de Haas K, Altamura S, Muckenthaler MU, Niederwieser D, Al-Ali HK. Efficacy and safety of deferasirox in non-thalassemic patients with elevated ferritin levels after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2016 Jan;51(1):89-95. doi: 10.1038/bmt.2015.204. Epub 2015 Sep 14.

    PMID: 26367238RESULT

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 Pharmeceuticals

    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

April 2, 2008

First Posted

April 8, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

DE(1)