NCT03670901

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: JHL Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 Subjects evaluated as progressive disease (PD) should be withdrawn from the study treatment and their subsequent treatments will be determined by the investigator.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.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	JHL1101	JHL1101, 100mg/10mL
BIOLOGICAL	MabThera	Rituximab, 100mg/10mL

Timeline

• Start date: 2018-11-13
• Primary completion: 2019-03-07
• Completion: 2019-03-07
• First posted: 2018-09-14
• Last updated: 2020-01-09

Locations

1 site across 1 country: China