A Phase I/II Study of Revlimid (Lenalidomide) in Combination With Vidaza (Azacitidine) in Patients With Advanced Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- PHASE I: Maximum Tolerated Dose of Azacitidine
研究概览
简要总结
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and azacitidine in patients with advanced myelodysplastic syndromes (MDS).
Secondary
- Review clinical outcomes, as defined by the International Working Group criteria, in patients treated with this regimen.
- Determine time to transformation to acute myeloid leukemia or death in patients treated with this regimen.
- Determine time to relapse after achieving complete or partial remission in patients treated with this regimen.
- Determine time to disease progression in patients treated with this regimen.
- Determine the effect of this regimen on hematologic status (including peripheral blood counts and the need for platelet and/or red blood cell transfusions) in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lenalidomide and Azacitidine
干预措施: azacitidine (Drug)
Lenalidomide and Azacitidine
干预措施: lenalidomide (Drug)
结局指标
主要结局
PHASE I: Maximum Tolerated Dose of Azacitidine
时间窗: After 1 courses (1 months)
Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard "3+3" design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.
PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)
时间窗: After 7 courses (months)
For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement) Complete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones. Partial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality. Hematologic Improvement (HI) is defined as: red blood cell increase of \>=1.5g/dL, a platelet response of \>=30X10\^9/L or by at least 100% for values starting \<20X10\^9/L, or a neutrophil response of at least 100% and absolute increase of \>0.5X10\^9/L
PHASE I: Maximum Tolerated Dose of Lenalidomide
时间窗: After 1 courses (1 months)
Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard "3+3" design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.
次要结局
- Time to Transformation to Acute Myeloid Leukemia or Death(After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months)
- Time to Relapse After Achieving Complete Response(After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months)
- Number of Patients That Experience Grade 3 or 4 Treatment Related Non-hematologic Adverse Events(After 7 months)
- Overall Survival Among Patients With Complete Response(After 7 months of treatment, until the date of first documented myeloid leukemia or death, whichever came first, assessed up to 55 months)
研究者
Mikkael Sekeres MD
Principal Investigator
Case Comprehensive Cancer Center