EUCTR2007-000766-20-GB进行中（未招募）1 期
A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 197
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age =10 years.
- •Male or female patients with ß-thalassemia major or DBA or myelodysplsatic syndromes (MDS) (low and INT-1 risk as per the IPSS for MDS) or sideroblastic anemia on chronic transfusion therapy, having given written consent to participate in the study.
- •Myocardial T2* value that is = 6 but not >20 ms. Patients enrolled with a baseline T2* less than 10 ms will undergo additional CMR assessments, every 3 months, to evaluate cardiac function and cardiac iron as part of safety monitoring.
- •Lifetime history of at least 50 units of red cell transfusions, and must be receiving at least =10 units/yr of red blood cells transfusions.
- •LVEF = 56 % as determined by CMR.
- •LIC = 3 mg Fe / g dw, as determined by R2 MRI.
- •Only patients chelated or who need any chelation therapy. Chelated patients will undergo a 5-day washout period prior to commencing 12 month study treatment.
- •Are the trial subjects under 18? yes
- •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
排除标准
- •Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias).
- •Patients unable to undergo study assessments including MRI, who:
- •Are claustrophobic to MRI.
- •Have a pacemaker, ferromagnetic metal implants other than those approved as safe for use in MR scanners (e.g., some types of aneurysm clips, shrapnel in proximity to vital organs such as the retina).
- •Are obese (exceeding the equipment limits).
- •Patients with serum creatinine > ULN or with significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) =1.0mg/mg in a non-first void urine sample at baseline. If serum creatinine is found to be >ULN or UPCR is found to be =1mg/mg the test can be repeated after 1 month.
- •Patients with ALT (SGPT) levels > 5 x ULN only if their LIC is <10mg Fe/g dw. If ALT is found to be >5 x ULN and LIC <10mg Fe/g dw the test can be repeated after 1 month.
- •Patients with considerable impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox / ICL670 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- •History of clinically relevant ocular and/or auditory toxicity related to iron chelation therapy.
- •Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol.
- •Patients with a known history of HIV seropositivity (Elisa or Western blot).
- •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •Pregnant, nursing or at risk of becoming pregnant
- •Participating in another clinical trial or receiving an investigational drug.
- •History of non-compliance with medical regimens or considered potentially unreliable and/or not cooperative, unwilling or unable to comply with the protocol
- •Patients with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption
- •History of hypersensitivity to any of the study drugs or their excipients
研究者
相似试验
进行中（未招募）
不适用
A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - NDMedDRA version: 9.1Level: LLTClassification code 10043388Term: ThalassaemiathalassemiaEUCTR2007-000766-20-ITOVARTIS FARMA192
招募中
1 期
Study evaluating AGuIX® nanopartcles in combinaison with radiotherapy for progressive / recurrent inoperable musculoskeletal tumor lesion.EUCTR2021-000571-37-FRCentre Léon Bérard132
进行中（未招募）
1 期
Combination of Talazoparib with Enzalutamide in Metastatic Prostate Cancer previously Treated with Abiraterone : TEAM PCProstate CancerCTIS2023-510536-37-00Fundacion Oncosur78
进行中（未招募）
1 期
Clinical trial comparing the safety and efficacy of pimasertib and dacarbazine in previously untreated patients with locally advanced or metastatic malignant cutaneous melanoma showing the so-called N-Ras mutation.-RAS mutated locally advanced or metastatic malignant cutaneous melanomaMedDRA version: 18.1Level: LLTClassification code 10025655Term: Malignant melanoma of skinSystem Organ Class: 100000004864EUCTR2012-002669-37-DEMerck Serono S.A. Geneva184
进行中（未招募）
1 期
Clinical trial comparing the safety and efficacy of pimasertib and dacarbazine in previously untreated patients with locally advanced or metastatic malignant cutaneous melanoma showing the so-called N-Ras mutation.-RAS mutated locally advanced or metastatic malignant cutaneous melanomaMedDRA version: 18.0Level: LLTClassification code 10025655Term: Malignant melanoma of skinSystem Organ Class: 100000004864EUCTR2012-002669-37-NLMerck Serono S.A. Geneva184