Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Disease stabilization
研究概览
简要总结
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML relapse within one year after transplantation
- •Blood and marrow sampling being possible
- •Expected survival at least 4 weeks
- •No expected drug interactions
- •Informed consent possible
排除标准
- •Intolerance to any study drug
- •Serious kidney or liver disease
- •Informed consent not possible
- •Previous pancreatitis
研究组 & 干预措施
1
Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions
干预措施: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions. (Drug)
结局指标
主要结局
Disease stabilization
时间窗: 5 years
Strict criteria defined in the protocol.
次要结局
- Survival(5 years)
研究者
Øystein Bruserud
Professor
University of Bergen