NCT05814718尚未招募不适用
Multicenter Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Carmustine, Etoposide and Cytarabine (Modified BEAM Protocol) for T Cell Lymphoma Underwent Autologous Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- relapse rate of T cell lymphoma
研究概览
简要总结
A multicenter randomized study on the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with carmustine, etoposide, and cytarabine (modified BEAM protocol) in the pretreatment of T-cell lymphoma underwent autologous stem cell transplantation
详细描述
T-cell lymphoma patients with the indication of autologous stem cell transplantation will be divided into two groups，the control group will use BEAM as conditioning regimen and the experiment group will use modified BEAM regimen（included mitoxantrone liposome，then to compare the efficacy and safety of the two conditioning regimens for patients.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with follow-up 2) 18~60 years old (including upper and lower limits) 3) Patients who were pathologically diagnosed as T-cell lymphoma and planned to undergo autologous hematopoietic stem cell transplantation 4) ECOG score 0-1 5) Organ function level must meet the following requirements:
- •Liver: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤ 1.5 × ULN (AST, ALT ≤ 5 is allowed in case of liver invasion × ULN）；
- •Kidney: blood creatinine ≤ 1.5 × ULN；
- •Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN；
- •Normal cardiac function: normal or abnormal ECG, no clinical significance, left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 60, or myocardial zymogram CK-MB is normal, and pro BNP is less than 900 pg/ml 6) The serum pregnancy test results of female subjects with reproductive capacity must be negative before the first use of the test drug
排除标准
- •1.The previous anti-tumor treatment history of the subject meets one of the following conditions:
- •Those who have previously received mitoxantrone or mitoxantrone liposomes
- •Have received doxorubicin or other anthracyclines before, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin for other anthracyclines)
- •Hypersensitivity to any study drug or its components
- •Uncontrollable systemic diseases (such as active infection, uncontrollable hypertension, diabetes, etc.)
- •Heart function and disease meet one of the following conditions:
- •Long QTc syndrome or QTc interval>480 ms
- •Complete left bundle branch block, grade II or III atrioventricular block
- •Serious and uncontrolled arrhythmia requiring drug treatment
- •American New York Heart Association rating ≥ III
- •Cardiac ejection fraction (LVEF) is less than 60%
- •A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormality within 6 months before recruitment.
- •Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL, hepatitis C virus RNA exceeds 1x103 copies/mL)
- •Human immunodeficiency virus (HIV) infection (HIV antibody positive)
- •Have had or are suffering from other malignant tumors at the same time (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled in the past five years)
- •Have primary or secondary CNS lymphoma or have a history of CNS lymphoma at the time of recruitment
- •Pregnant and lactating women and childbearing age patients unwilling to take contraceptive measures
- •Those who have a history of drug abuse (use of narcotic drugs or psychotropic drugs for non-medical purposes) or dependence on drugs (sedative hypnotics, analgesics, narcotics, stimulants, and psychotropic drugs, etc.)
- •History of mental illness or cognitive impairment
- •Other investigators judged that it was not suitable to participate in this study.
研究组 & 干预措施
modified BEAM conditioning regimen
Experimental
Mitoxantrone liposome 24 mg/m2，ivgtt，d-7；BCNU 300 mg/m2，ivgtt，d-6； Ara-C 200 mg/m2 q12h，ivgtt，d-5- -2； Vp16 200 mg/m2 ，ivgtt，d-5- -2；
干预措施: modified BEAM (Drug)
BEAM conditioning regimen
Active Comparator
BCNU 300 mg/m2，-7d； Vp16 200 mg/m2，-6～-3d； Ara-C 100mg/m2 q12h，-6～-3d； Mel 140mg/m2，-2d
干预措施: BEAM (Drug)
结局指标
主要结局
relapse rate of T cell lymphoma
时间窗: three years after transplantation
relapse rate at three years after transplantation
次要结局
- AEs(from beginning of the conditioning to one month after conditioning)
- PFS(From date of HSCT until the end of follow-up or the date of disease relapse from any cause, whichever came first，assessed up to 36 months.)
- immune reconstruction(At 6 months post-transplantation)
- OS(From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.)
研究者
研究点 (1)
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