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CompletedNCT01459887Updated Oct 26, 2011

Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma

A Phase 3 interventional study of CHOP combined with CMAB304 and CHOP, CMAB304 in Diffuse Large B Cell Lymphoma, sponsored by Shanghai CP Guojian Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-10-26.

Sponsored by Shanghai CP Guojian Pharmaceutical Co., Ltd. (part of 3SBio Inc.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

CD20, the protein which is expressed on the surface of all mature B cells, is active in many B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL), the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases. This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP chemotherapy regimen compared with CHOP chemotherapy alone.

Read the detailed description

Rituximab, a chimeric anti-CD20 monoclonal antibody, has been proved valuable treatment for CD20-positive DLBCL. The combination of rituximab with CHOP has been shown to increase both survival and response rate, in comparison to CHOP alone. CMAB304(Retuxira), a biosimilar of rituximab, was developed by Shanghai CP Guojian Pharmaceutical Co.,Ltd. Previous Phase I study showed that CMAB304 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 250 to 500 mg/m2. In this study, efficacy and safety of CMAB304 were evaluated in DLBCL patients.

02

Conditions studied

  • Diffuse Large B Cell Lymphoma

Keywords

  • untreated, CD20-positive
03

In context

Lymphoma, Large B-Cell, Diffuse

1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.

This study's enrollment of 278 is above the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Shanghai CP Guojian Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

First submitted before Shanghai CP Guojian Pharmaceutical Co., Ltd. became part of 3SBio Inc..

Browse Shanghai CP Guojian Pharmaceutical Co., Ltd. studies →All 3SBio Inc. studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age from 18 to 70 year, male or female
  2. Previously untreated
  3. DLBCL patients with CD20-positive
  4. Lymphoma lesions can be Measured and evaluated; Spiral CT or MR evaluation of the lesion must be ≥ 1cm; Measured by clinical examination or others must be ≥ 2cm
  5. Normal blood test, adequate liver and renal function;
  6. ECOG score 0\~2
  7. Life expectancy of greater than 3 months
  8. No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
  9. Signed ICF

Exclusion criteria

Exclusion Criteria:

  1. DLBCL transformed from other low-grade NHL types
  2. Primary central nervous system lymphoma, or primary gastrointestinal DLBCL
  3. History of foreign protein allergies
  4. Abnormal liver and/or renal function
  5. Suspected or diagnosed central nervous system violation
  6. Serious infection or organic diseases
  7. Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months
  8. Breastfeeding or pregnant
  9. Leukemia crisis or bone marrow metastases
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
278 participants (actual)

Study arms

  • Experimental
    combination group

    Drug: CHOP combined with CMAB304

  • Experimental
    sequential group

    Drug: CHOP, CMAB304

Interventions

  • DrugCHOP combined with CMAB304

    Patients treated with CHOP-304 undergo 1 cycle every 3 weeks, received CMAB304 at a dose of 375 mg/m2 on day 1 and CHOP on day 2 of each of the 6 cycles.

    Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone

  • DrugCHOP, CMAB304

    First standard CHOP, then sequential CMAB304 in patients who reached a complete response or undocumented complete response at the end of treatment of 6 cycles.

    Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone

06

What researchers measure

Primary outcomes

  1. overall response rate

    Tumor responses were assessed after 6 cycles of CMAB304-CHOP or 6 cycles of CHOP alone and classified as CR,CRu,PR,SD or PD.

    Time frame: up to 18 weeks

Secondary outcomes

  1. event-free survival

    Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause.

    Time frame: From date of randomization until the date of first documented progression or relapse, institution of a new anticancer treatment, or death from any cause, whichever came first, assessed up to 50 months

07

Study locations

1 site
  • SUN-YAT-SEN university cancer center
    Guangzhou, Guangdong 510060, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2006, a primary completion of Dec 2010 and a completion of Feb 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2011
First posted
Oct 26, 2011
Start
Sep 2006
Primary completionActual
Dec 2010
CompletionActual
Feb 2011
Last update
Oct 26, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01459887
Lead sponsor
Shanghai CP Guojian Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 26, 2011
Start date
Sep 2006
Primary completion
Dec 2010
Completion
Feb 2011
Last update
Oct 26, 2011

Study contacts

Jun Zhu, PhD
principal investigator · Peking University Cancer Hospital & Institute
Daobin Zhou, PhD
principal investigator · Peking Union Medical College Hospital
Weijing Zhang, PhD
principal investigator · Affiliated Hospital of Chinese PLA Military Academy of Medical Sciences
Yiping Zhang, PhD
principal investigator · Zhejiang Cancer Hospital
Jifeng Feng, PhD
principal investigator · Jiangsu Cancer Institute & Hospital
Yu Yang, PhD
principal investigator · Fujian Cancer Hospital
Qitao Yu, PhD
principal investigator · Cancer Hospital of Guangxi Medical University
Yuankai Shi, PhD
principal investigator · Cancer Institute ＆Hospital. China Academy of Medical Sciences
Lugui Qiu, PhD
principal investigator · Tianjin Hematonosis Hospital
Ting Liu, PhD
principal investigator · West China Hospital
Wenbin Qian, PhD
principal investigator · First Affiliated Hospital of Zhejiang University
Ping Zou, PhD
principal investigator · Union Hospital of Tongji Medical College of Huazhong University of Science ＆ Technology
Zhongzhen Guan, PhD
study chair · Sun Yat-Sen University Cancer Center
Huiqiang Huang, PhD
study director · Sun Yat-Sen University Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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