A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.
详细描述
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed, written informed consent
- •Have untreated AML according to World Health Organization (WHO) classification
- •Male or post-menopausal female ≥ 65 years of age
- •Unsuitable for intensive chemotherapy
- •Be able to comply with study procedures and follow-up examination
- •Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
- •Have adequate liver and renal function as indicated by certain laboratory values
排除标准
- •Received previous treatment with clofarabine
- •Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
- •Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
- •Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
- •Have an active, uncontrolled systemic infection
- •Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
- •Have symptomatic central nervous system (CNS) involvement
- •Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
研究组 & 干预措施
Clofarabine
Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
干预措施: clofarabine (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: At month 20
ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
次要结局
- Duration of Overall Response(From 20 months up to 48 months)
- Overall Survival(From 20 months up to 48 months)
- Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)(At month 20)
- Duration of Complete Remission(From 20 months up to 48 months)