An Multicenter, Randomized, Controlled, Prospective Clinical Study of Mitoxantrone Liposome Combined With PTCy as Conditioning Regimen in Allo-HSCT in Acute Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study intends to evaluate the efficiency and safety of M-PTCy as conditioning regimen in Haploidentical HSCT for Acute Leukemia, so as to provide a new conditioning regimen for allogeneic hematopoietic cell transplantation.
详细描述
Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Posttransplant cyclophosphamide (PTCy) has revolutionized Haplo HCT with acceptable rates of engraftment, graft-versus-host disease (GVHD), relapse, and survival.To prolonger PFS, OS and alleviate GVHD, we combined Mitoxantrone liposomes with PTCy as conditioning regimen in allogeneic hematopoietic cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients meet the diagnostic criteria for acute leukemia(except APL).
- •Expecting life span is more than 3 months.
- •The patients intended allogeneic hematopoietic stem cell transplantation.
排除标准
- •Previously received doxorubicin or other anthracycline therapy, the total cumulative dose of doxorubicin≥360 mg/m
- •Cardiac function and disease meet one of the following conditions:
- •Long QTc syndrome or QTc intervalgt≥480 ms;
- •Complete left bundle branch block, grade II or III Degree atrioventricular block;
- •Severe, uncontrolled arrhythmia requiring drug treatment;
- •New York Society of Cardiology class ≥ II;
- •Cardiac ejection fraction (LVEF) lower than 50% or lower than the study The lower limit of the central laboratory test value range;
- •History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically serious pericardial disease history within 6 months before recruitment, or ECG evidence of acute ischemia or active conduction system abnormalities.
- •Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN); Total bilirubin > 1.5 times upper limit of normal; Serum creatinine > 1.5 times the upper limit of normal.
- •Suffering from other malignant tumors in the past or at the same time ;
- •Exclude patients with severe active infection or other underlying diseases who cannot tolerate chemotherapy;
- •Human immunodeficiency virus (HIV) infected patients (HIV antibody positive);
- •Active hepatitis B and C infection；
- •Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study;
- •Severe mental disorders who do not cooperate with treatment;
- •Judgment by the investigator , There are patients who are not suitable to participate in this study.
研究组 & 干预措施
M+PTCy group
For the M-PTCy group, Mitoxantrone liposomes with 36mg/m2 and Bu 3.2mg/kg -5 to -4, Flu 30mg/m2 -12 to -9, Ara-C 1.5g/m2 -12 to -9，CTX 15mg/kg/d -3 to -2, was used as conditioning regimen, Post Transplant Cyclophosphamide 50 mg/kg IV daily on days +3 and +4.
干预措施: mitoxantrone liposome (Drug)
BuCy group
For the BUCY group, the conditioning regimen involved Ara-C 2g/m2 q12h -8, BU 3.2 mg/kg -7 to -5,CTX 1.8 g/m2 -4 to -3, to prevent GVHD, MTX 15mg/m2 +1d, 10mg/m2 +3,+6,+11,CsA 3mg/kg/d from -8d,MMF 1g q12h from -8d， ATG 2.5mg/kg/d -5 to -2.
干预措施: ATG (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From the 1st day to 2 years after enrollment
It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.
次要结局
- Overall survival (OS)(From the 1st day to 2 years after enrollment)
- CMV and EBV activation(From the 1st day to 2 years after enrollment)
- incidence of GVHD(From the 1st day to 2 years after enrollment)