Diffuse Large B Cell LymphomaPhase 3NCT01459887
Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma
A Phase 3 study testing CHOP combined with CMAB304 and CHOP, CMAB304 in people with Diffuse Large B Cell Lymphoma, run by Shanghai CP Guojian Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- CHOP combined with CMAB304 and CHOP, CMAB304
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- Sep 2006to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 70 year, male or female
- Previously untreated
- DLBCL patients with CD20-positive
- 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
- Normal blood test, adequate liver and renal function;
- ECOG score 0~2
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- Life expectancy of greater than 3 months
- No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
- Signed ICF
Who cannot join
- DLBCL transformed from other low-grade NHL types
- Primary central nervous system lymphoma, or primary gastrointestinal DLBCL
- History of foreign protein allergies
- Abnormal liver and/or renal function
- Suspected or diagnosed central nervous system violation
- Serious infection or organic diseases
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- Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months
- Breastfeeding or pregnant
- Leukemia crisis or bone marrow metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL
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.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- CHOP combined with CMAB304, CHOP, CMAB304
- Keywords
- untreated, CD20-positive
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP combined with CMAB304Drug
Also called cyclophosphamide, doxorubicin, vincristine, prednisone
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.
CHOP, CMAB304Drug
Also called cyclophosphamide, doxorubicin, vincristine, prednisone
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.
| Study group | Role | What they receive |
|---|---|---|
| combination group | Experimental | Not described Receives: Drug: CHOP combined with CMAB304 |
| sequential group | Experimental | Not described Receives: Drug: CHOP, CMAB304 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startSep 2006
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai CP Guojian Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Zhu, PhD, Principal investigator, Peking University Cancer Hospital & InstituteDaobin Zhou, PhD, Principal investigator, Peking Union Medical College HospitalWeijing Zhang, PhD, Principal investigator, Affiliated Hospital of Chinese PLA Military Academy of Medical SciencesYiping Zhang, PhD, Principal investigator, Zhejiang Cancer HospitalJifeng Feng, PhD, Principal investigator, Jiangsu Cancer Institute & HospitalYu Yang, PhD, Principal investigator, Fujian Cancer HospitalQitao Yu, PhD, Principal investigator, Cancer Hospital of Guangxi Medical UniversityYuankai Shi, PhD, Principal investigator, Cancer Institute ＆Hospital. China Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459887
- Sponsor's protocol ID
- 304NHL-050617
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL
- ClinicalTrials.gov ID
- NCT01459887
- Acronym / sponsor ID
- 304NHL-050617
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- untreated, CD20-positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Shanghai CP Guojian Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination group | Experimental | Drug: CHOP combined with CMAB304 |
| sequential group | Experimental | Drug: CHOP, CMAB304 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age from 18 to 70 year, male or female
- Previously untreated
- DLBCL patients with CD20-positive
- 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
- Normal blood test, adequate liver and renal function;
Key exclusion criteria (9 listed)
- DLBCL transformed from other low-grade NHL types
- Primary central nervous system lymphoma, or primary gastrointestinal DLBCL
- History of foreign protein allergies
- Abnormal liver and/or renal function
- Suspected or diagnosed central nervous system violation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOP combined with CMAB304Also: cyclophosphamide, doxorubicin, vincristine, prednisonePatients 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. | Drug | combination group |
| CHOP, CMAB304Also: cyclophosphamide, doxorubicin, vincristine, prednisoneFirst standard CHOP, then sequential CMAB304 in patients who reached a complete response or undocumented complete response at the end of treatment of 6 cycles. | Drug | sequential group |
Primary outcome
overall response rate
Time frame: up to 18 weeks
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.
1 secondary outcome
event-free survival
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHOP combined with CMAB304 and CHOP, CMAB304 in people with Diffuse Large B Cell Lymphoma, run by Shanghai CP Guojian Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.