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

• Status: Withdrawn
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Cyclophosphamide; Mitoxantrone; Prednisone; Vincristine

Criteria

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;