NCT05299164进行中（未招募）1 期
Liposomal Mitoxantrone Hydrochloride, Gemcitabine, Vinorelbine With or Without Rituximab (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a prospective, dose-escalation clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
详细描述
This is a single-arm, single-center, dose-escalation clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, vinorelbine and/or rituximab (GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). Liposomal mitoxantrone hydrochloride will be given on day 1 at four different doses (16 mg/m2, 18 mg/m2, 20 mg/m2,22 mg/m2) and be combined with gemcitabine, vinorelbine and/or rituximab (rituximab only in CD20+ lymphoma). The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects fully understand and voluntarily participate in this study and sign the informed consent
- •Age ≥18, ≤70years, no gender limitation
- •Expected survival ≥ 3 months;
- •Histologically confirmed diagnosis of aggressive NHL.
- •Subjects with relapsed or refractory NHL. Relapsed disease is defined as the disease relapsing after CR or PR, and the duration of prior response is more than 6 months. Refractory disease can be confirmed if any of the following conditions are met: 1) no PR or CR has been obtained after previous treatment; 2) CR / PR was achieved after prior therapy, but recurred within 6 months; 3) Recurrence after hematopoietic stem cell transplantation.
- •Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be > 1.5cm; For non-lymph node lesions, the length and diameter should be > 1.0cm;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) : 0-1
- •The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/ L, Hemoglobin(HB)≥ 80g/L, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Serum creatinine (Scr) ≤1.5X ULN.
排除标准
- •The subject had previously received any of the following anti-tumor treatments:
- •Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;
- •Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin);
- •Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs within 4 weeks before the first administration of the study drugs;
- •Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first administration of study drugs;
- •Hypersensitivity to any study drug or its components;
- •Uncontrolled systemic diseases (such as active infection, uncontrolled 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 arrhythmias requiring drug treatment;
- •New York Heart Association grade ≥ III;
- •Cardiac ejection fraction (LVEF)# 50%;
- •A history of myocardial infarction, unstable angina pectoris, 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 abnormalities within 6 months before recruitment.
- •Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x103 copy/mL; hepatitis C virus RNA high than 1x103 copy/mL)
- •Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive)
- •Patients with other malignant tumors, except for effectively controlled non- melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors without treatment during the past 5 years.
- •Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- •Unsuitable subjects for this study determined by the investigator.
研究组 & 干预措施
Liposomal mitoxantrone hydrochloride 16 mg/m^2 (with a caret included)
Experimental
干预措施: Liposomal Mitoxantrone Hydrochloride dose level 1 (Drug)
Liposomal mitoxantrone hydrochloride 18 mg/m^2 (with a caret included)
Experimental
干预措施: Liposomal Mitoxantrone Hydrochloride dose level 2 (Drug)
Liposomal mitoxantrone hydrochloride 20 mg/m^2 (with a caret included)
Experimental
干预措施: Liposomal Mitoxantrone Hydrochloride dose level 3 (Drug)
Liposomal mitoxantrone hydrochloride 22 mg/m^2 (with a caret included)
Experimental
干预措施: Liposomal Mitoxantrone Hydrochloride dose level 4 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Through the last patient complete his DLT observation, assessed up to 21 days
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in GVM±R
次要结局
- Dose limited toxicities (DLTs)(Through the last patient complete his DLT observation, assessed up to 21 days)
- The incidence rates of AE and SAE(up to 28 days after the last patient complete his study therapy)
- Complete response rate (CRR)(: up to 2 years)
- progression-free survival（PFS）(up to 2 years)
- Objective response rate (ORR)(up to 2 years)
研究者
研究点 (1)
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