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

A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/d) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654589

Enrollment

Registered

2008-04-08

Start date

2008-02-29

Completion date

2012-01-31

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Overload

Keywords

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

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.

Interventions

DRUGDeferasirox

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. Other protocol-defined inclusion/

Design outcomes

Primary

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

Secondary

Measure	Time frame
To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.	52 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026