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

August 11, 2020 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tianjin, China
        • Institute of Hematology; Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBI301
IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Six cycles. IBI301: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.
Active Comparator: Rituximab
Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Six cycles. Rituximab: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate(ORR)
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival(PFS)
Time Frame: 1 year
1 year
Overall survival(OS)
Time Frame: 1 year
1 year
Complete remission(CR)
Time Frame: 18 weeks
18 weeks
Event-free survival(EFS)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2016

Primary Completion (Actual)

September 5, 2019

Study Completion (Actual)

December 26, 2019

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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