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A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL

NCT04361279 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2023-12-27

No results posted yet for this study

Summary

This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China.

In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

SIBP-02

Injection，100mg/10ml

DRUG

Rituximab

Injection，100mg/10ml

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Shanghai Institute Of Biological Products Co., Ltd · SINOPHARM

  • The First Affiliated Hospital of College of Medicine · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2022-05-20
Completion
2022-05-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04361279 on ClinicalTrials.gov