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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02595242
• Other study ID #: CSPC-HE1505/PRO/?
• Status: Withdrawn
• Phase: Phase 1
• First received: November 2, 2015
• Last updated: May 22, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: May 2017
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide 750 mg/m2 will be infused intravenously once 1-2 minutes in 20-30 ml saline on the first day during a treatment phase of 3 weeks.
• Vincristine
Vincristine 0.3-0.5 mg/ml will be infused intravenously once about 5 minutes in saline on the first day during a treatment phase of 3 weeks.
• Prednisone
Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks.

Locations

Country	Name	City	State
China	Tianjin people's Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(Objective response rate)		12 Weeks