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

Who is this study for? Patients with Diffuse Large B-cell Lymphoma
What treatments are being studied? CHOP
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Tie Xu, Master
xutie@yoko-bio.com
86-18036618680
Time Frame
Start Date: 2018-12-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 360
Treatments
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.
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.
Sponsors
Leads: Nanjing Yoko Biomedical Co., Ltd.

This content was sourced from clinicaltrials.gov

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