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Rituximab

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Single dose IV infusion of 375 mg/m2 of JHL1101

Single dose IV infusion of 375 mg/m2 of Rituximab

100 mg/10 mL solution in a single-use vial

JHL1101

Lu-Gui Qiu, MD

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.

A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients

"A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients"

Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration

AUC from time 0 of the first infusion on Day 1 extrapolated to infinity

JHL Biotech, Inc.

Lymphoma, Large B-Cell, Diffuse

Diffuse Large B-Cell Lymphoma

375 mg/m2 of JHL1101 is given intravenously on D1 of each cycle

375 mg/m2 of Rituximab is given intravenously on D1 of each cycle

MabThera

Jun Zhu, MD/PhD

Approximately 500 subjects will be enrolled in this study. Subjects who meet the inclusion criteria will be randomized (1:1) into two groups. The study group will receive JHL1101 in combination with CHOP regimen, and the control group will receive rituximab (MabThera) in combination with CHOP. The dose of 375 mg/m2 is given intravenously on Day 1 (D1) of each cycle, and CHOP regimen is administered after the infusion of JHL1101 or rituximab is completed. Efficacy evaluation will be performed at baseline, after 3 cycles treatment (D18± 2 of Cycle 3, before the next cycle of treatment) and after 6 cycles treatment (D21±3 of Cycle 6). Subjects evaluated as progressive disease (PD) should be withdrawn from the study treatment and their subsequent treatments will be determined by the investigator. The analysis of primary endpoint is the ORR over the 6-cycle treatment period.

A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

A Multinational, Randomized, Double-blind, Positive-controlled, Parallel Study to Compare the Efficacy and Safety of JHL1101 in Combination With CHOP (J-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

To compare the overall response rate after 6 cycles treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients	NCT03670888	B Cell Lymphoma	JHL1101 Rituximab	18 Years - 75 Years	JHL Biotech, Inc.
A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)	NCT03670901	Diffuse Large B...	JHL1101 MabThera	18 Years - 70 Years	JHL Biotech, Inc.
A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)	NCT03670901	Diffuse Large B...	JHL1101 MabThera	18 Years - 70 Years	JHL Biotech, Inc.
A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)	NCT03670901	Diffuse Large B...	JHL1101 MabThera	18 Years - 70 Years	JHL Biotech, Inc.

Spots Global Cancer Trial Database for jhl1101

Every month we try and update this database with for jhl1101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for jhl1101

Every month we try and update this database with for jhl1101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for jhl1101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.