Differentiation Induction Therapy for Acute Myelogenous Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used to achieve disease control and stabilize peripheral blood counts in patients with acute myelogenous leukemia.
Adult patients (<18 years of age) who can be included: Elderly patients (>60 years of age) with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or resistant AML. Patients with relapsed or resistant AML who cannot receive intensive chemotherapy.
Treatment: Patients will be treated with all-trans retinoic acid (oral administration), valproic acid (7 days intravenous administration and later oral administration)and theophyllamine (7 days intravenous administration and later oral administration). Duration of treatment at least 2 months or until disease progression. Maximal duration of treatment 2 years.
Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.
详细描述
Patients to be included:
- Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
- Adult patients of any age (> 18 years of age)with relapsed or resistant AML who cannot receive conventional intensive chemotherapy or allogeneic stem cell transplantation.
We plan to include at least 20 patients, but if possible 30 patients during a 3 years period. The first patient was included November 2004.
Treatment:
All-trans retinoic acid (ATRA) administered orally 22.5 mg/m2 twice daily for 14 days, repeated every third month.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recently diagnosed acute myelogenous leukemia (AML)
- •Patients above 60 years of age
- •Patients who cannot receive conventional chemotherapy
- •Patients with relapsed or refractory AML independent of age
排除标准
- •Chronic myelogenous leukemia in blast phase
- •Intolerance to the study drugs
- •Serious liver disease
- •No informed consent
研究组 & 干预措施
ATRA plus valproic acid plus theophyllin
ATRA for 14 days, continuous treatment with valproic acid and theophyllin
干预措施: all-trans retinoic acid (ATRA) (Drug)
ATRA plus valproic acid plus theophyllin
ATRA for 14 days, continuous treatment with valproic acid and theophyllin
干预措施: Valproic acid (Drug)
ATRA plus valproic acid plus theophyllin
ATRA for 14 days, continuous treatment with valproic acid and theophyllin
干预措施: Theophyllin (Drug)
结局指标
主要结局
Survival
时间窗: 2008
次要结局
- Disease complications(2008)
- Side effects of therapy(2008)
- Disease stabilisation(2008)
研究者
Øystein Bruserud
Professor
University of Bergen