Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00481143
First received: May 31, 2007
Last updated: November 2, 2011
Last verified: November 2011
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Purpose
The purpose of this study is to investigate the effects of iron chelation using deferasirox in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS patients who show signs of iron overload due to repeated blood transfusions.
This trial is not recruiting patients in the United States.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes Transfusion Dependent Iron Overload |
Drug: ICL670/Deferasirox |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 in Patients Diagnosed With Low and INT-1 Risk Myelodysplastic Syndrome (MDS) and Transfusion-dependent Iron Overload |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of deferasirox assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 63 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: deferasirox |
Drug: ICL670/Deferasirox
Other Name: ICL670
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- MDS patients presenting with low or intermediate-1 IPSS risk and transfusional iron overload
- Patients of either gender and age ≥ 18 years
- History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs)
- Patients can be either naïve to iron chelation or have had prior treatment with deferoxamine (DFO) or deferiprone (L1)
- Females of childbearing potential must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
Exclusion Criteria:
- Non-transfusion related iron overload
- Treatment with deferasirox (ICL670) before study start
- Patients with a concomitant malignant disease
- Patients with out of range lab values
- History of nephrotic syndrome
- Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
- Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
- Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days
- Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- Patients with active uncontrolled infectious disease
- Pregnancy or breast feeding
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00481143 History of Changes |
| Other Study ID Numbers: | CICL670ADE03 |
| Study First Received: | May 31, 2007 |
| Last Updated: | November 2, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Novartis:
|
Myelodysplastic Syndrome MDS iron overload chelation chelators ICL670 Deferasirox serum ferritin |
LIC transfusional hemosiderosis Refractory Anemia RA Refractory Anemia with Ringed Sideroblasts RARS blood transfusions Mydelodysplastic Syndrome(s) |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Iron Overload Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms |
Iron Metabolism Disorders Metabolic Diseases Deferasirox Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013