Phase 3 Study of Recombinant Erythropoetin and Adjuvant I.V. Iron Therapy of Anemic Patients With Lymphoproliferative Disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.
研究概览
简要总结
This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.
详细描述
In this multi-center, randomized, open label phase-3 study, the correction of mild or moderate anemia and the effect on iron kinetics by rHuEPO treatment, with or without intravenous iron treatment, in patients with LPD not receiving antineoplastic therapy will be studied.
LENGTH OF STUDY 16 weeks
NUMBER OF CENTERS 15
NUMBER OF SUBJECTS 66
STRATIFICATION 1. According to diagnosis; CLL and indolent NHL vs. MM. 2. According to level of S-epo > 100 IU/L vs £ 100 IU/L at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma, indolent NHL or CLL
- •Anemia of cancer with a Hb concentration within the range ³ 90 - £ 110 g/L measured at two different occasions with at least two weeks interval but inclusion within 4 weeks after the first Hb measurement.
- •Age >18 years.
- •Informed consent in writing.
- •Demonstration of stainable iron in bone-marrow aspirate.
排除标准
- •Planned or expected antineoplastic therapy (except systemic low dose maintenance corticosteroids) within the 6 weeks following inclusion.
- •Cytostatic or any other antitumor therapy (except systemic low dose maintenance corticosteroids) within 8 weeks before inclusion.
- •RBC transfusion within 8 weeks before inclusion.
- •RHuEPO treatment within 12 weeks before inclusion.
- •Any iron therapy within 4 weeks before inclusion.
- •Ongoing infectious disease.
- •Active inflammatory disease other than the malignant disease.
- •Performance status ³ 3 according to the ECOG scale.
- •Folate deficiency (S-folate < 4,5 nmol/L).
- •B12 deficiency (S-cobalamin < 145 pmol/L).
- •Ongoing haemolysis defined as S-haptoglobin < 0,2 g/L
- •Impaired kidney function (S-Creatinine > 175 mmol/L)
- •Acute or chronic clinical relevant hepatic dysfunction (S-bilirubin >40 umol/L)
- •S-Ferritin >800 ug/L
- •Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.
- •Unstable or uncontrolled disease related to or affecting cardiac function e.g., unstable angina, congestive heart failure (NYHA>Class ll), uncontrolled hypertension (diastolic BP >100 mmHg) and/or uncontrolled cardiac arrhythmia.
- •Known history of allergy to any of the study medications or their excipients.
- •Concurrent treatment with experimental drugs not approved by Läkemedelsverket.
- •Male and female patients with reproductive potential must use an approved contraceptive method (e.g. intrauterine device (IUD), birth control pills or barrier device) during the study and for 3 months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
结局指标
主要结局
To compare the mean change in hemoglobin (Hb) concentrations from baseline to EOT (End of treatment ) between the two treatment groups.
次要结局
- The percentage of subjects with Hb response defined by an increase in the Hb concentration by at least 20 g/L in the absence of any RBC transfusion.
- The time needed to obtain a Hb response.
- The fraction of subjects receiving RBC transfusions during the study period.
- The dose of rHuEPO used.
- The effect on iron-status.
- The weekly Hb concentration profile over time.
- The frequency and grade of adverse reactions.