Diffuse Large B-Cell Lymphoma, Unspecified SitePhase 3NCT03650933
A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients
A Phase 3 study testing G-CHOP and R-CHOP in people with Diffuse Large B-Cell Lymphoma, Unspecified Site, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
Trial summary
A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Unspecified Site
- What is being tested?
- G-CHOP and R-CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2018to 31 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated CD20 Positive DLBCL.
- International Prognostic Index (IPI) score of 0 to 2, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 18 years to 70 years; Male or female patients; Body Mass Index (BMI)≤2.13 m^2.
- Expected survival more than 6 months.
- At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter≥1.5cm and short axis≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm.
- Cardiac echocardiography: LVEF≥50%.
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- Adequate hematological function: WBC≥3 x 10^9/L, HGB≥80g/L, ANC≥1.5 x 10^9/L, PLT≥75 x 10^9/L.
- Hepatic function: TBIL≤1.5 x ULN, ALT or AST≤2.5 x ULN, ALP≤3 x ULN if with no bone marrow infiltration, Renal function: Cr≤1.5 x ULN.
- Seronegative for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated.
- Must agree to take effective birth control methods or are not of childbearing potential. Women must agree to continue contraceptive measures within 12 months after the last treatment. Men must agree to continue contraception within 3 months after the treatment.
- All patients must have signed an informed consent document.
Who cannot join
- Other types of DLBCL: primary central nervous system DLBCL, primary skin DLBCL (leg type), EBV-positive DLBCL, NOS, EB virus-positive skin mucosal ulcer, chronic inflammation-related DLBCL, lymphomatoid granuloma, primary Mediastinal (thymus) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmablastic lymphoma, primary exudative lymphoma, HHV8+DLBCL, NOS, Burkitt's lymph Tumor, primary testicular lymphoma。
- Confirmed DLBCL with BCL-2 and c-MYC gene rearrangement or BCL-2, BCL-6, and c-MYC gene rearrangement by FISH. B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma.
- B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma.
- Previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer.
- Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy);
- Patients who received continuous treatment of corticosteroid drugs lasting for more than 10 days. Prednisone with the dosage over 30mg/day; Other corticosteroid drugs with equal dosage.
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- Patients who received cytotoxic drugs or anti-CD20 monoclonal antibody for other diseases (such as Rheumatoid arthritis).Or received any monoclonal antibody within 3 months prior to the enrollment of the study.
- Patients who participated in other clinical trials within 3 months prior to the enrollment of the study.
- Patients who received attenuated or live virus vaccine within 1 month prior to the enrollment of the study.
- Patients who received hematopoietic stimulating factors within 1 week prior to the enrollment of the study.
- Recent major surgery within 1 month.
- Active Infectious disease or significant infections requiring intravenous antibiotic therapy or hospitalization in the past 4 weeks (exception of tumor induced fever).
- Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
- Contraindicative to any drug in CHOP.
- Patients who have significant cardiac disease, including heart disease of grade Ⅲ of Ⅳ according to the New York Heart Association(NYHA) system, or occurrence of myocardial infarction, unstable arrhythmia, unstable angina or severe hypertension in the past 6 months or peripheral nervous system(PNS) or CNS disease.
- Suspected active tuberculosis patients.
- Patients with serious peripheral nervous system or central nervous system disease.
- Patients that researchers deem as not appropriate to enter the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
yuankai Shi, Doctor, 010-67781331, syuankaipumc@126.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients
A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients
- Being tested
- G-CHOP, R-CHOP
- Keywords
- GB241, Rituximab, Diffuse Large B-cell Lymphoma, Non Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CHOPBiological
6 cycles(each cycle is 3 weeks)
R-CHOPBiological
6 cycles(each cycle is 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| G-CHOP | Experimental | GB241 plus CHOP, six cycles. GB241: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle. Receives: Biological: G-CHOP |
| R-CHOP | Active comparator | Rituximab plus CHOP, six cycles. Rituximab: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle. Receives: Biological: R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six cycles of treatment.
Measured: 6 cycles(each cycle is 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start28 Dec 2018
- Primary completion17 Aug 2022
- Study completion31 Dec 2025 (estimated)
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 Lymphoma, Unspecified SiteStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650933
- Sponsor's protocol ID
- GB241NHL3
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients
- ClinicalTrials.gov ID
- NCT03650933
- Acronym / sponsor ID
- GB241NHL3
- Keywords
- GB241, Rituximab, Diffuse Large B-cell Lymphoma, Non Hodgkin's Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2018 (actual)
- 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.
A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CHOP | Experimental | Biological: G-CHOPGB241 plus CHOP, six cycles. GB241: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle. |
| R-CHOP | Active comparator | Biological: R-CHOPRituximab plus CHOP, six cycles. Rituximab: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Previously untreated CD20 Positive DLBCL.
- International Prognostic Index (IPI) score of 0 to 2, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 18 years to 70 years; Male or female patients; Body Mass Index (BMI)≤2.13 m^2.
- Expected survival more than 6 months.
- At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter≥1.5cm and short axis≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm.
Key exclusion criteria (18 listed)
- Other types of DLBCL: primary central nervous system DLBCL, primary skin DLBCL (leg type), EBV-positive DLBCL, NOS, EB virus-positive skin mucosal ulcer, chronic inflammation-related DLBCL, lymphomatoid granuloma, primary Mediastinal (thymus) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmablastic lymphoma, primary exudative lymphoma, HHV8+DLBCL, NOS, Burkitt's lymph Tumor, primary testicular lymphoma。
- Confirmed DLBCL with BCL-2 and c-MYC gene rearrangement or BCL-2, BCL-6, and c-MYC gene rearrangement by FISH. B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma.
- B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma.
- Previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer.
- Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy);
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 |
|---|---|---|
| G-CHOP6 cycles(each cycle is 3 weeks) | Biological | G-CHOP |
| R-CHOP6 cycles(each cycle is 3 weeks) | Biological | R-CHOP |
Primary outcome
Objective response rate (ORR)
Time frame: 6 cycles(each cycle is 3 weeks)
To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six cycles of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
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 G-CHOP and R-CHOP in people with Diffuse Large B-Cell Lymphoma, Unspecified Site, run by Nanjing Yoko Biomedical 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 11 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tie Xu, Master (86-18036618680, xutie@yoko-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 6 cycles(each cycle is 3 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 20 Feb 2024.