A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 117
- 主要终点
- Overall Survival
研究概览
简要总结
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
详细描述
This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML based on WHO (World Health Organization) classification
- •Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Adequate renal function
- •Adequate liver function
- •Able to swallow capsules
- •Agree to practice effective contraception
- •Ability to understand and willingness to sign the informed consent form
排除标准
- •AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
- •Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
- •Known or suspected central nervous system (CNS) involvement by leukemia
- •Uncontrolled intercurrent illness
- •Known hypersensitivity to decitabine
- •Known to be HIV-positive
研究组 & 干预措施
Sapacitabine-decitabine alternating
Arm A sapacitabine administered in alternating cycles with decitabine
干预措施: Sapacitabine (Drug)
Sapacitabine-decitabine alternating
Arm A sapacitabine administered in alternating cycles with decitabine
干预措施: Decitabine (Drug)
Decitabine
Arm C Decitabine
干预措施: Decitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: up to 43 months
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
次要结局
- Complete Remission With Incomplete Platelet Count Recovery (CRp)(up to 43 months)
- 1-year Survival(Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage).)
- Partial Remission (PR)(up to 43 months)
- Stable Disease (SD)(up to 43 months)
- Complete Remission (CR)(up to 43 months)
- Hematological Improvement(up to 43 months)
- Blood Products Transfused(up to 43 months)
- Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)(up to 43 months)
- Duration of Hematological Improvement (dHI)(up to 43 months)
- Duration of Stable Disease (dSD)(up to 43 months)
- Hospitalized Days(up to 12 months)
- Duration of Partial Remission (dPR)(up to 43 months)
- Duration of Complete Remission (dCR)(up to 43 months)