An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •diagnosis of MDS, according to International Prognostic Scoring System (IPSS) criteria;
- •low or intermediate risk, who are not candidates for treatment with growth factors, or who have not responded to these treatments.
排除标准
- •previous treatment with CellCept, or any erythropoietin-stimulating drug;
- •diagnosis of proliferative chronic myelomonocytic leukemia;
- •prior or concomitant malignancies other than MDS, with the exception of basocellular, spinocellular or adequately treated in situ cervical cancer, in the past 3 years;
- •biological antitumor and myelosuppressive treatment within 28 days before start of study;
- •bone marrow precursor cell transplantation previous to study.
研究组 & 干预措施
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
干预措施: Mycophenolate mofetil (Drug)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
干预措施: Prednisone (Drug)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
干预措施: Erythropoietin Beta (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
时间窗: Up to approximately 2 years
International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) \<11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.
Mean Number of Blood Transfusions Per Visit
时间窗: Up to approximately 2 years
次要结局
- Percentage of Participants With at Least One Adverse Event (AE)(Up to approximately 2 years)