- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650933
A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients
February 18, 2024 updated by: Nanjing Yoko Biomedical Co., Ltd.
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
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tie Xu, Master
- Phone Number: 86-18036618680
- Email: xutie@yoko-bio.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital Chinese Academy of Medical Sciences
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Contact:
- yuankai Shi, Doctor
- Phone Number: 010-67781331
- Email: syuankaipumc@126.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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%.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G-CHOP
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.
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6 cycles(each cycle is 3 weeks)
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Active Comparator: R-CHOP
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.
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6 cycles(each cycle is 3 weeks)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 6 cycles(each cycle is 3 weeks)
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To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six cycles of treatment.
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6 cycles(each cycle is 3 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2018
Primary Completion (Actual)
August 17, 2022
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
August 27, 2018
First Submitted That Met QC Criteria
August 27, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 18, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GB241NHL3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diffuse Large B-Cell Lymphoma, Unspecified Site
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Zhejiang UniversityShanghai First Song Therapeutics Co., LtdNot yet recruitingHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Gray Zone Lymphoma | NK/T Cell Lymphoma | Peripheral T Cell Lymphoma, Unspecified | Mediastinal B-Cell Diffuse Large Cell LymphomaChina
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Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenActive, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | CD20 Positive | Stage I Diffuse Large B-Cell Lymphoma | Stage II Diffuse Large B-Cell Lymphoma | Stage III Diffuse Large B-Cell Lymphoma | Stage IV Diffuse Large B-Cell LymphomaUnited States
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Qian WenbinNot yet recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaChina
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University Hospital Southampton NHS Foundation...Hoffmann-La RocheTerminatedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited Kingdom
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National Cancer Institute (NCI)WithdrawnDiffuse, Large B-cell Lymphoma | Lymphoma, Diffuse Large-Cell | Lymphoma, Diffuse Large-Cell B-cell | Large-Cell Lymphoma, Diffuse
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Dana-Farber Cancer InstituteBayer; AbbVieActive, not recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited States
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Memorial Sloan Kettering Cancer CenterSanofi; Columbia University; Medical College of Wisconsin; University of Rochester and other collaboratorsActive, not recruitingDiffuse Large B-cell Lymphoma (DLBCL) | Relapsed Diffuse Large B-cell Lymphoma (DLBCL) | Refractory Diffuse Large B-cell Lymphoma (DLBCL)United States
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Autolus LimitedCompletedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | DLBCL | Relapsed Diffuse Large B-Cell LymphomaUnited States, United Kingdom
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Herlev HospitalOdense University Hospital; Zealand University Hospital; Aarhus University Hospital and other collaboratorsCompletedDiffuse Large B-cell Lymphoma Recurrent | Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma Cell of Origin
Clinical Trials on G-CHOP
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Fondazione Italiana Linfomi - ETSRecruiting
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The First Affiliated Hospital of Xiamen UniversityThe First Affiliated Hospital with Nanjing Medical University; Sun Yat-sen... and other collaboratorsRecruitingFollicular Lymphoma | DLBCL - Diffuse Large B Cell LymphomaChina
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Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, JapanTerminatedNon-Hodgkin's LymphomaJapan
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Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, JapanCompleted
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Emergent BioSolutionsTerminated
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Yune ZhaoUnknownHard Nuclear Cataract | Corneal Endothelial Cell | Progressive Cracking TechniqueChina
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Sherief Abd-ElsalamRecruiting
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Ruijin HospitalActive, not recruitingPeripheral T-cell LymphomaChina
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Sun Yat-sen UniversityCompletedDiffuse Large B-cell Lymphoma
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Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingPeripheral T-cell Lymphoma