Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Diffuse Large B Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT04491721

NCC2288

Details and patient eligibility

About

The main objective of this study is to observe the overall survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL. The secondary objective of this study is to observe the progression-free survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.

Full description

1. Enrollment:407 subjects.
2. The inclusion criteria of this study: subjects who have participated in Phase III clinical trials.Phase III clinical trial（NCT02787239） has ended.
3. The exclusion criteria: ①Subjects died; ②Subjects are unwilling to participate in follow-up study; ③ the investigator judges that the subject is not suitable for participating the study.
4. Duration and method of follow-up: 2-10 years (2020-2027)after the end of the Phase III trial and follow up the subjects by the phone.
5. Statistical analysis method: For progression-free survival and overall survival (OS), the median time and its 95% confidence intervals will be calculated by the Kaplan-Meier method.The Log-Rank test will be used for finding the difference between groups. The efficacy will be analyzed by SAS9.4 , and all hypothesis tests are two-sided. The confidence level of all confidence intervals is 95%. P value less than 0.05 was regarded as statistically significant.

Enrollment: 407 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have participated in Phase III study（NCT02787239）.

Exclusion criteria

• ①Subjects died; ②Subjects are unwilling to participate in follow-up study; ③ the investigator judges that the subject is not suitable for participating the study.

Trial design

407 participants in 2 patient groups

Rituximab Biosimilar HLX01 in Combination With CHOP

Description:

Rituximab Biosimilar HLX01 in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL.

MabThera in Combination With CHOP

Description:

MabThera in Combination With CHOP，in Previously Untreated Subjects With CD20+ DLBCL.