DRKS00004366招募中2 期
Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Multiple Myeloma or Lymphoma
OXXON Pharma AG0 个研究点目标入组 48 人开始时间: 2012年9月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.Written informed consent
- •2.Female or male aged >18 years
- •3.Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven multiple myeloma, M. Hodgkin, or non-Hodgkin lymphoma of any grade or stage:
- •Hemoglobin (Hb) 7.0 g/dL to 10 g/dL,
- •Transferrin saturation (TSAT) <20%,
- •Serum iron <50 µg/dL
- •Ferritin >30 ng/mL
- •4.Previous treatment with systemic anti-cancer therapy / regimen
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of =2
- •6.Estimated life expectancy =12 weeks
排除标准
- •1.Inability to personally provide written informed consent or to understand and collaborate throughout the study
- •2.History of pure red cell aplasia, thalassemia major or sickle cell disease
- •3.History of anemia unrelated to cancer <10 g/dL within 6 months prior to screening
- •4.Uncorrected iron deficiency
- •5.Regular need for blood transfusions at intervals <6 weeks
- •6.Acute or myeloid leukemia
- •7.Suspected or known history of hemochromatosis
- •8.Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
- •9.Impaired liver function with bilirubin =2.0 mg/dL (26 µmol/L), AST or ALT =2 times upper limit
- •10.History of hepatic cirrhosis or organ transplantation
- •11.Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min (Cockcroft-Gault)
- •12.Known central nervous system malignancy or metastasis
- •13.Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure [BP] >150 mmHg or diastolic BP >100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
- •14.Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
- •15.Previous participation in this study or treatment with an investigational agent <21 days prior to treatment start
- •16.Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to treatment start
- •17.Treatment with erythropoiesis-stimulating agents (ESAs) or red blood cell (RBC) transfusions <21 days prior to treatment start
- •18.Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (e.g. lenalidomide, interferon)
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