NCT02867566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

August 22, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2019

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

August 11, 2016

Last Update Submit

August 11, 2020

Conditions

Diffuse, Large B-Cell, Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate(ORR)

    18 weeks

Secondary Outcomes (4)

  • Complete remission(CR)

    18 weeks

  • Progression-free survival(PFS)

    1 year

  • Event-free survival(EFS)

    1 year

  • Overall survival(OS)

    1 year

Study Arms (2)

IBI301

EXPERIMENTAL

IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Drug: IBI301 plus CHOP

Rituximab

ACTIVE COMPARATOR

Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Drug: Rituximab plus CHOP

Interventions

IBI301 plus CHOPDRUG

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.

IBI301
Rituximab plus CHOPDRUG

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.

Rituximab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Untreated CD20-positive DLBCL confirmed by histopathology or cytology.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology; Chinese Academy of Medical Sciences

Tianjin, China

Location

Related Publications (1)

  • Song Y, Zhou H, Zhang H, Liu W, Shuang Y, Zhou K, Lv F, Xu H, Zhou J, Li W, Wang H, Zhang H, Huang H, Zhang Q, Xu W, Ge Z, Xiang Y, Wang S, Gao D, Yang S, Lin J, Wang L, Zou L, Zheng M, Liu J, Shao Z, Pang Y, Xia R, Chen Z, Hou M, Yao H, Feng R, Cai Z, Zhang M, Ran W, Liu L, Zeng S, Yang W, Liu P, Liang A, Zuo X, Zou Q, Ma J, Sang W, Guo Y, Zhang W, Cao Y, Li Y, Feng J, Du X, Zhang X, Zhao H, Zhou H, Yu J, Sun X, Zhu J, Qiu L. Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial. Adv Ther. 2021 Apr;38(4):1889-1903. doi: 10.1007/s12325-020-01603-8. Epub 2021 Mar 9.

    PMID: 33751401DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lugui Qiu

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

August 22, 2016

Primary Completion

September 5, 2019

Study Completion

December 26, 2019

Last Updated

August 12, 2020

Record last verified: 2016-08

Locations

CN(1)