Safety and Efficacy Study of CNOP Chemotherapy in Diffuse Large B Cell Lymphoma
Phase 1
Withdrawn
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Registration Number
- NCT02595242
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief Summary
The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.
- Detailed Description
Mitoxantrone Hydrochloride Liposome Injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. The investigator´s phaseⅠstudy has shown that the drug´s toxicity is manageable and the tolerable does is 20 mg/m2. The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Written informed consent prior to study specific screening procedures;
- Favorable index of curative effect of Diffuse Large B Cell Lymphoma confirmed by histological analysis;
- ≥ 18 and ≤ 70 years of age, male or female;
- Advanced Lymphoma and standard treatments failed;
- May benefit from anthracycline-based drugs;
- ECOG performance status of 0-2;
- More than 4 weeks from the last chemotherapy, more than 4 weeks from the last biotherapy, more than 4 weeks from the last clinical trial drug therapy;
- Life expectancy of more than 3 months;
- Sexually active women of childbearing potential must use a medically acceptable form of contraception;
- Adequate hepatic, renal, cardiac and hematologic functions: leukocyte≥3.5×10^9/L,neutrophils≥2.0×10^9/L,platelets≥100×10^9/L, hemoglobin≥90g/L,creatinine clearance rate≤1.5×ULN, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), alkaline phosphatase≤200 IU/L,Electrocardiogram appeared to be essentially normal, ejection fraction of Heart Doppler ultrasound appeared to be normal.
Exclusion Criteria
- Pregnant or lactating women;
- Patients with Multiple sclerosis;
- Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, Active peptic ulcer;
- Mitoxantrone has been used before;
- The cumulative does of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively;
- Heart disease was caused after Anthracycline-based drugs used;
- Other antineoplastic drugs need to be used in this study;
- History of Anthracycline-based drug allergy or liposome drug allergy;
- Uncontrolled primary brain tumor or brain metastases;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mitoxantrone 12 mg/m2 Cyclophosphamide Mitoxantrone Hydrochloride Liposome Injection 12 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 12 mg/m2 Vincristine Mitoxantrone Hydrochloride Liposome Injection 12 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 12 mg/m2 Prednisone Mitoxantrone Hydrochloride Liposome Injection 12 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 16 mg/m2 Cyclophosphamide Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 16 mg/m2 Vincristine Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 16 mg/m2 Prednisone Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 20mg/m2 Cyclophosphamide Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 20mg/m2 Vincristine Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks. Mitoxantrone 20mg/m2 Prednisone Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5％ glucose injection on the first day during a treatment phase of 3 weeks.
- Primary Outcome Measures
Name Time Method ORR(Objective response rate) 12 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tianjin people's Hospital
🇨🇳Tianjin, China