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

Diffuse, Large B-Cell, Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867566
• Other study ID #: CIBI301A301
• Status: Completed
• Phase: Phase 3
• Start date: August 22, 2016
• Est. completion date: December 26, 2019

Study information

• Verified date: August 2016
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 26, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse, Large B-Cell, Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Institute of Hematology; Chinese Academy of Medical Sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate(ORR)		18 weeks
Secondary	Complete remission(CR)		18 weeks
Secondary	Progression-free survival(PFS)		1 year
Secondary	Event-free survival(EFS)		1 year
Secondary	Overall survival(OS)		1 year