Venetoclax for Prevention of Differentiation Syndrom (DS) in Acute Promyelocytic Leukemia (APL) Patients : An Open-lable, Single-arm, Multicenter, Phase Ⅱ Clinical Trail
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- the rate of differential symdrom
研究概览
简要总结
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
- •patients must have confirmation of APL by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance < 45 mL/min. Moderate hepatic impairment with total bilirubin > 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
排除标准
- •Patient is ineligible for treatment with intensive chemotherapy
- •Patient with active infection not controlled, active bleeding from vital organs
- •Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
研究组 & 干预措施
Arm Description:the Venatoclax regimen to prevent DS
The patient with suspected APL should be treated with ATRA or Venetoclx depending on its WBC counts and rapid diagnosis of APL was made at the same time. Once APL was diagnosed, patients were initially treated with ATRA 25 mg/m2/d and ATO 0.16 mg/kg/d. During the induction regimen, patients in whom the WBC counts increased to more than 2 × 109/L received Venetoclax and DS was suspected received dexamethasone or ruxolitinib.
干预措施: venetoclax (Drug)
结局指标
主要结局
the rate of differential symdrom
时间窗: the induction regimen (21 days to 28 days)
DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure.
次要结局
未报告次要终点