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WithdrawnNCT02595242Updated May 23, 2017

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

A Phase 1 interventional study of Cyclophosphamide and Vincristine in Diffuse Large B Cell Lymphoma, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Withdrawn at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

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Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Mitoxantrone 12 mg/m2

    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

  • Experimental
    Mitoxantrone 16 mg/m2

    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

  • Experimental
    Mitoxantrone 20mg/m2

    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

  • DrugCyclophosphamide

    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.

  • DrugVincristine

    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.

  • DrugPrednisone

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

06

What researchers measure

Primary outcomes

  1. ORR(Objective response rate)

    Time frame: 12 Weeks

07

Study locations

1 site
  • Tianjin people's Hospital
    Tianjin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02595242
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Nov 3, 2015
Start date
Jun 2015
Primary completion
Dec 2016 (estimated)
Completion
Jun 2017 (estimated)
Last update
May 23, 2017

Study contacts

Huaqing Wang, Ph.D
principal investigator · Tianjin People's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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