Clinical Trials /

A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients

NCT03650933

Description:

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

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GB241NHL3
  • NCT ID: NCT03650933

Conditions

  • Diffuse Large B-Cell Lymphoma, Unspecified Site

Interventions

DrugSynonymsArms
G-CHOPG-CHOP
R-CHOPR-CHOP

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
G-CHOPExperimentalGB241 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.
  • G-CHOP
R-CHOPActive ComparatorRituximab 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.
  • R-CHOP

Eligibility Criteria

        Inclusion Criteria:

          1. Previously untreated CD20 Positive DLBCL.

          2. International Prognostic Index (IPI) score of 0 to 2, Eastern Cooperative Oncology
             Group (ECOG) performance status of 0 to 2.

          3. 18 years to 70 years; Male or female patients; Body Mass Index (BMI)≤2.13 m^2.

          4. Expected survival more than 6 months.

          5. 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.

          6. Cardiac echocardiography: LVEF≥50%.

          7. 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.

          8. 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.

          9. 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.

         10. 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.

         11. All patients must have signed an informed consent document.

        Exclusion Criteria:

          1. 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。

          2. 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.

          3. B-cell lymphoma, unclassifiable, with features intermediate between diffuse large
             B-cell lymphoma and classical Hodgkin lymphoma.

          4. Previous malignant tumor except cured cervical cancer,basal cell carcinoma and
             squamous cell skin cancer.

          5. Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy,
             immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody
             therapy; surgical treatment (excluding biopsy);

          6. 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.

          7. 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.

          8. Patients who participated in other clinical trials within 3 months prior to the
             enrollment of the study.

          9. Patients who received attenuated or live virus vaccine within 1 month prior to the
             enrollment of the study.

         10. Patients who received hematopoietic stimulating factors within 1 week prior to the
             enrollment of the study.

         11. Recent major surgery within 1 month.

         12. Active Infectious disease or significant infections requiring intravenous antibiotic
             therapy or hospitalization in the past 4 weeks (exception of tumor induced fever).

         13. Known allergic reactions against human or murine monoclonal antibody, murine products,
             or foreign proteins.

         14. Contraindicative to any drug in CHOP.

         15. 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.

         16. Suspected active tuberculosis patients.

         17. Patients with serious peripheral nervous system or central nervous system disease.

         18. Patients that researchers deem as not appropriate to enter the study.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:6 cycles(each cycle is 3 weeks)
Safety Issue:
Description:To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six cycles of treatment.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Nanjing Yoko Biomedical Co., Ltd.

Trial Keywords

  • GB241
  • Rituximab
  • Diffuse Large B-cell Lymphoma
  • Non Hodgkin's Lymphoma

Last Updated

August 27, 2018