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A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

A Multicenter, Randomized, Double-blind, Controlled, Phase III Study to Evaluate the Efficacy and Safety of IBI301 (Recombinant Chimeric Anti-CD20 Monoclonal Antibody ) in Combination With CHOP Regimen Versus Rituximab in Combination With CHOP Regimen in Treatment-naïve Patients With Diffuse Large B-cell Lymphoma (DLBCL)

NCT02867566•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Untreated CD20-positive DLBCL confirmed by histopathology or cytology.
•18 years to 75 years; Male or female patients.
•International Prognostic Index (IPI) score of 0 to 2.
•Signed an informed consent.
•At least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
•More than 6 months life expectancy.

Exclusion Criteria

•Participation in another interventional clinical trial in the past 3 months.
•Known allergic reactions against monoclonal antibody or rituximab.
•Contraindication to any component of CHOP regimen.
•Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month.
•History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
•Primary central nervous system (CNS) lymphoma, secondary CNS involvement, primary testicular lymphoma.

Locations (1)

Institute of Hematology; Chinese Academy of Medical Sciences

Tianjin, China

Key Dates

Start Date

August 22, 2016

Primary Completion Date

September 5, 2019

Completion Date

December 26, 2019

Last Updated

August 12, 2020

Enrollment

420

ACTUAL participants

Conditions

Diffuse, Large B-Cell, Lymphoma

Interventions

IBI301 plus CHOP

DRUG

Rituximab plus CHOP

DRUG

A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

NCT04236141

Diffuse, Large B-Cell, Lymphoma

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TERMINATEDPHASE2

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

NCT02374424

Diffuse, Large B-Cell, Lymphoma

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COMPLETEDPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)