Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
Long-term Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
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.
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.
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