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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04491721
Other study ID # NCC2288
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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