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

July 25, 2020 updated by: Shi Yuankai, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

407

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 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.
up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 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.
up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

June 1, 2027

Study Completion (Anticipated)

July 1, 2027

Study Registration Dates

First Submitted

July 25, 2020

First Submitted That Met QC Criteria

July 25, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 25, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2288

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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