Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL
NCT ID: NCT04491721
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
407 participants
OBSERVATIONAL
2020-07-31
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rituximab Biosimilar HLX01 in Combination With CHOP
Rituximab Biosimilar HLX01 in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL.
No interventions assigned to this group
MabThera in Combination With CHOP
MabThera in Combination With CHOP，in Previously Untreated Subjects With CD20+ DLBCL.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Shi Yuankai
chief physician
Principal Investigators
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Yuankai Shi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, , China
Countries
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Other Identifiers
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NCC2288
Identifier Type: -
Identifier Source: org_study_id
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