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

NCT02595242 | Withdrawn Phase 1

• 1 other identifier: CSPC-HE1505/PRO/Ⅰ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR(Objective response rate)

  12 Weeks

Study Arms (3)

Mitoxantrone 12 mg/m2

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone

Mitoxantrone 16 mg/m2

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone

Mitoxantrone 20mg/m2

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone

Interventions

Cyclophosphamide DRUG

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.

Mitoxantrone 12 mg/m2; Mitoxantrone 16 mg/m2; Mitoxantrone 20mg/m2

Vincristine DRUG

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.

Mitoxantrone 12 mg/m2; Mitoxantrone 16 mg/m2; Mitoxantrone 20mg/m2

Prednisone DRUG

Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks.

Mitoxantrone 12 mg/m2; Mitoxantrone 16 mg/m2; Mitoxantrone 20mg/m2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Tianjin people's Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Huaqing Wang, Ph.D

  Tianjin People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

CN (1)