Phase II Explorative Study of Intermittent Imatinib (IM) Treatment (INTERIM) in Elderly Patients With Ph+ Chronic Myeloid Leukemia (CML) Who Achieved a Stable Complete Cytogenetic Response (CCgR) With Standard IM Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The proportion of patients who remain in CCgR with INTERIM given for one year.
研究概览
简要总结
Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years) have similar cytogenetic responses and survival, but they usually show a low compliance. The aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with intermittent imatinib therapy with respect to standard daily administration.
详细描述
Objective: The aim of the study is to investigate if the complete cytogenetic response (CCgR) that has been achieved with standard (daily administration) Imatinib (IM) therapy can be maintained with the same dose of IM given intermittently (INTERIM). For the purposes of this study, the term "standard IM therapy" means the daily administration of IM at any dose between 300 and 800mg, whereas, "intermittent IM treatment" (INTERIM), is defined as the same daily dose of IM given one month on/one month off .
The primary objective of the study is to evaluate the proportion of patients who remain in CCgR with INTERIM given for one year.
Study design: This study is an open-label, multicenter, Phase II study of INTERIM for the maintenance of CCgR.
Study Population: Elderly patients (at least 65 years) with Ph+ CML and with stable CCgR after at least 2 years of standard (daily administration ) IM therapy
Treatment Plan STUDY DRUG: Imatinib is registered as Glivec by Novartis Pharma Italy for treatment of patients with Ph+ CML in any phase (CP and AP/BP).
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
- •Patients with confirmed diagnosis of Ph+ CML in CP
- •Age ≥ 65 years old
- •Stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
- •Karnofsky performance status >50%
- •Written informed consent prior to any study procedures being performed.
排除标准
- •Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP, previously treated (i.e. IFN alpha+/- low dose Ara-C, Hydroxyurea, allogeneic stem cell transplantation, etc etc.)
- •Age < 65 years old
- •No stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
- •Karnofsky performance status <50%
- •No written informed consent prior to any study procedures being performed.
研究组 & 干预措施
Intermittent Imatinib
Imatinib will be given with the following schedule:
- 1 week on / 1 week off for the 1st month(weeks 1-4)
- 2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12)
- 1 month on / 1 month off from the 4th month thereafter (weeks 13 on)
干预措施: Imatinib (Drug)
结局指标
主要结局
The proportion of patients who remain in CCgR with INTERIM given for one year.
时间窗: 1 year
次要结局
- Variation of BCR-ABL transcript level(1 year)
研究者
Domenico Russo
Full Professor of Hematology
Università degli Studi di Brescia