Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 22
- 主要终点
- Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement
研究概览
简要总结
We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]
详细描述
Subjects meeting all inclusion and exclusion criteria will receive lenalidomide
lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1-21, every 4 weeks.
Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and when clinically indicated/for assessment of disease progression) evaluations
Subjects may participate in the study for up to 52 weeks ( in patients still responding after 52 weeks, the drug wil continue to be supplied).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age > 18 years at the time of signing the informed consent form
- •MDS with IPSS scores Int-2 or high with deletion 5q(31)
- •Prior thalidomide allowed
- •Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q[31] (the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities
排除标准
- •Pregnant or lactating females
- •Prior therapy with lenalidomide
- •MDS with IPSS scores low or Int-1
- •Clinical neuropathy of greater than grade 2
- •Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML)
- •Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
- •Use of androgens other than for treating hypogonadism
结局指标
主要结局
Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement
次要结局
未报告次要终点