Trial | NCT02867566  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    420
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 Started
Aug 22
2016
Primary Completion
Sep 05
2019
Study Completion
Dec 26
2019
Last Update
Aug 12
2020

Drug IBI301 plus CHOP

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.

Drug Rituximab plus CHOP

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.

IBI301 Experimental

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

Rituximab Active Comparator

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

Criteria 

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.
No Results Posted