A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Di⦠(NCT02867566) | Clinical Trial Compass
CompletedPhase 3
A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
China420 participantsStarted 2016-08-22
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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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.