Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 主要终点
- Overall response rate
研究概览
简要总结
This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).
详细描述
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
Hydroxyurea was permitted as rescue medication if white blood count (WBC) was >20×109/L and but was discontinued at least 24h before decitabine treatment.
Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator.
Curative effect was evaluated after two cycles:
- <5% blast in the marrow, enter into maintenance therapy (Group A)
- ≥5% blast in the marrow, continue induction therapy two cycles,
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).
- •Age: ≥ 60 and ≤ 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 2ULN.
- •Without central nervous system symptoms.
- •Willing to accept the follow-up.
- •Normal heart function(EF>50%). The subjects volunteer to sign the informed consent.
排除标准
- •With severe cardiac, renal or hepatic insufficiency.
- •With other cancers requiring treatment.
- •With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).
- •With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).
- •Brain disorders or severe mental diseases which could limit compliance with study requirements.
- •Major operation within 3 weeks.
- •With HIV infection or AIDS-associated diseases.
- •Any drug abuse, medical, mental or social situations which would affect the results.
- •Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
研究组 & 干预措施
Acute myeloid leukemia
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
干预措施: Decitabine (Drug)
Acute myeloid leukemia
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
干预措施: Cytarabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: three years
complete remission rate
时间窗: three years
次要结局
- recurrence rate(three years)
- mortality rate(three years)
- Overall survival(three years)
- progression-free survival(three years)
研究者
Chunyan Ji
professor
Shandong University