Safety and Efficacy Study of CNOP Chemotherapy in Diffuse Large B Cell Lymphoma

Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma

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.

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.

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;