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

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04491721
• Other study ID #: NCC2288
• Status: Enrolling by invitation
• Start date: July 2020
• Est. completion date: July 2027

Study information

• Verified date: July 2020
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 407
• Est. completion date: July 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
China	Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival	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.	up to 8 years