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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Withdrawn

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Cyclophosphamide

Vincristine

Prednisone

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Tianjin people's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Mitoxantrone 12 mg/m2

Mitoxantrone 16 mg/m2

Mitoxantrone 20mg/m2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

ORR(Objective response rate)

Secondary Outcome Measures

Full Information

NCT ID

NCT02595242

First Posted

November 2, 2015

Last Updated

May 22, 2017

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02595242

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Withdrawn

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mitoxantrone 12 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

Mitoxantrone 16 mg/m2

Arm Type

Experimental

Arm Description

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.

Arm Title

Mitoxantrone 20mg/m2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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

Primary Outcome Measure Information:

Title

ORR(Objective response rate)

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huaqing Wang, Ph.D

Organizational Affiliation

Tianjin People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin people's Hospital

City

Tianjin

Country

China

12. IPD Sharing Statement

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

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