Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 5 Days Every Month) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Dependent Versus Best Supportive Care (BSC) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Independent
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 6
- 主要终点
- Event Free Survival (EFS)
研究概览
简要总结
The goal of this clinical research study is to compare how 2 different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS. The safety of each study drug given on these schedules will also be studied.
This is an investigational study. Decitabine and azacitidine are both FDA approved and commercially available for use in patients with MDS. Giving these drugs on a different schedule than is standard is considered investigational.
The study doctor can tell you how the study drugs are designed to work.
详细描述
Study Groups and Study Drug Administration:
Each cycle is approximately 28 days.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 4 groups:
- If you are in Group 1, you will receive decitabine by vein over about 1 hour on Days 1-3 of every cycle.
- If you are in Group 2, you will receive azacitidine either as an injection under your skin or by vein on Days 1-3 of every cycle.
- If you are in Group 3, you will receive azacitidine either as an injection under your skin or by vein on Days 1-5 of every cycle.
- If you are in Group 4, you will receive the standard of care. The study doctor can explain the treatment you will receive and the risks involved.
Transfusion-dependent participants will be randomly assigned to 1 of 3 groups
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 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an IRB-approved informed consent document.
- •Age >/= 18 years.
- •IPSS low- or intermediate-1-risk MDS, including CMML-1
- •ECOG performance status of </= 3 at study entry.
- •Organ function defined as: Serum creatinine </= 2 mg/dL; Total bilirubin </= 2 x ULN; ALT (SGPT) </= 2 x ULN; AST (SGOT) </= 2 x ULN
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
排除标准
- •Breast feeding females
- •Prior therapy with decitabine or azacitidine
研究组 & 干预措施
Azacitidine (AZA) - Days 1 - 3
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
干预措施: Azacitidine (AZA) Days 1 - 3 (Drug)
Azacitidine (AZA) - Days 1 - 5
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
干预措施: Azacitidine (AZA) Days 1 - 5 (Drug)
Decitabine (DAC)
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
干预措施: Decitabine (DAC) (Drug)
Best Supportive Care (BSC)
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
干预措施: Best Supportive Care (BSC) (Other)
结局指标
主要结局
Event Free Survival (EFS)
时间窗: Up to 8 years, 9 months and 12 days
Event free survival (EFS) defined as the time from beginning of treatment till an event occurs or last follow-up. For transfusion independent patients, the events includes lack of response, requirement of blood transfusion, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death. For transfusion dependent patients, the events includes lack of response, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death.
次要结局
- Number of Participants With Overall Improvement(Up to 8 years, 9 months and 12 days)