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Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload

NCT ID: NCT00654589

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Overload

Keywords

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Hematopoietic stem cell transplantation HCT iron overload chelators ICL670 deferasirox serum ferritin LIC transfusional hemosiderosis blood transfusions adults iron chelation 3-6 months allogeneic hematopoietic stem cell transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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deferasirox

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

Interventions

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Deferasirox

Intervention Type DRUG

Other Intervention Names

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ICL670

Eligibility Criteria

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Inclusion Criteria

1. Transfusional iron overload three to six months after HCT with no evidence of active inflammation
2. History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
3. Patients of either gender and age ≥ 18 years.
4. 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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Leipzig, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 26367238 (View on PubMed)

Other Identifiers

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CICL670ADE02

Identifier Type: -

Identifier Source: org_study_id