A one-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral ICL670 (20 mg/kg/day) in patients three to six months after allogeneic hematopoietic cell transplantation in whom iron overload is present

• Conditions: allogeneic hematopoietic cell transplantation with iron overload; MedDRA version: 9.1Level: LLTClassification code 10001756Term: Allogenic bone marrow transplantation therapy

• Registration Number: EUCTR2006-003970-89-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Transfusional iron overload three to six months after HCT (mean serum ferritin level > 1000 ng/ml) with no evidence of active inflammation (C-reactive protein [CAP] < 10 mg/l) at the time of measurement.
2.Patients must have engrafted with ANC > 1000 /mm³.
3.History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
4.Patients of either gender and age = 18 years.
5.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. Only contraception with a pearl-Index below 1% should be considered.
6.Written informed consent by the patient.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Non-transfusion related hemosiderosis
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 HCT
6.Uncontrolled systemic hypertension
7.Serum creatinine > 1.5 ULN
8.History of nephrotic syndrome.
9.Previous history of clinically relevant ocular toxicity related to iron chelation.
10.Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
11.Psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing study treatment.
12.Pregnant or breast feeding patients.
13.Treatment with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days as well as the simultaneous participation in other clinical trials.
14.Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:
•history of inflammatory bowel syndrome, ulcers, gastrointestinal or rectal bleeding;
•history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
•history of pancreatic injury or pancreatitis; indications of impaired pancreatic function/injury as indicated by abnormal lipase or amylase;
•history of urinary obstruction or difficulty in voiding
15.History of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative.
16.History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening period.
17.QT > 470 msec on screening ECG.
18.Torsades de Pointes risk (patients with congenital long QT syndrome, heart insufficiency NYHA II-IV etc.).
19.Active GVHD at the time of enrolment.
20. History of clinically relevant auditory toxicity in combination with chelation therapy.
21. Galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
22. Simultaneous consumption of aluminium-containing antacid preparations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified