Clinical trial NCT02595242: Safety and Efficacy Study of CNOP Chemotherapy in Diffuse Large B Cell Lymphoma
Official title: Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: ORR(Objective response rate)
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin people's Hospital
Study officials:
affiliation: Tianjin People's Hospital
name: Huaqing Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: