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

NCT03670901 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-01-09

No results posted yet for this study

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 Subjects evaluated as progressive disease (PD) should be withdrawn from the study treatment and their subsequent treatments will be determined by the investigator.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

BIOLOGICAL

JHL1101

JHL1101, 100mg/10mL

BIOLOGICAL

MabThera

Rituximab, 100mg/10mL

Sponsors & Collaborators

  • JHL Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Jun Zhu, MD/PhD · Beijing Cancer Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2019-03-07
Completion
2019-03-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670901 on ClinicalTrials.gov