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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04491721

Enrollment

407

Registered

2020-07-29

Start date

2020-07-31

Completion date

2027-07-31

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B Cell Lymphoma

Keywords

rituximab, overall survival, progression-free survival

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
overall survival	up to 8 years	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.

Secondary

Measure	Time frame	Description
progression-free survival	up to 8 years	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.

Countries

China

Outcome results