Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL
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
1 other identifier
observational
407
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 25, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 29, 2020
July 1, 2020
6.9 years
July 25, 2020
July 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
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.
up to 8 years
Secondary Outcomes (1)
progression-free survival
up to 8 years
Study Arms (2)
Rituximab Biosimilar HLX01 in Combination With CHOP
Rituximab Biosimilar HLX01 in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL.
MabThera in Combination With CHOP
MabThera in Combination With CHOP，in Previously Untreated Subjects With CD20+ DLBCL.
Eligibility Criteria
Subjects who have participated in Phase III study. Phase III study（NCT02787239）was rituximab biosimilar HLX01 and MabThera in patients with diffuse large B-cell lymphoma.
You may qualify if:
- Subjects who have participated in Phase III study（NCT02787239）.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuankai Shi, Doctor
Chinese Academy of Medical Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
July 25, 2020
First Posted
July 29, 2020
Study Start
July 1, 2020
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
July 29, 2020
Record last verified: 2020-07