A Prospective Single Center Study of Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence and severity of differentiation syndrome
研究概览
简要总结
With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.
详细描述
Adults ages 18-75 with primary acute promyelocytic leukemia.
Design:
The induction therapy with ATRA 25mg/m2/d and ATO 10mg/kg/d should be started as soon as the diagnosis of APL confirmed.
Intravenous dexamethasone at a dose of 5-20 mg daily must be started if the WBC count greater than 5e+9/L (before or during the treatment with ATRA) as prevention or preemptive therapy of DS.
Idarubicin (4-10 mg/m2 /d*3d) and hydroxyurea（1.0-3.0g/d）can be given as leukocyte lowering therapy which may lessen the risk of DS.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary acute promyelocytic leukemia.
- •ECOG score≤
- •Must be able to understand and willing to participate in the study and sign the informed consent.
排除标准
- •Refractory/secondary acute promyelocytic leukemia.
- •Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
- •Clinically uncontrolled active infections.
- •Malignant tumors with other progresses.
- •Ecg: QT interval > 450 ms.
- •Allergic to arsenic agent.
- •Pregnant or lactating women.
结局指标
主要结局
incidence and severity of differentiation syndrome
时间窗: during the induction treatment
All symptoms and signs associated to DS should be paid closely attention to.
complete remission rate
时间窗: during the induction treatment
complete remission rate after treated by the induction regimen with ATRA and Arsenite
次要结局
- overall survival(from the day of first patient treatment up to 36 months after the last patient's enrollment)