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

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04491721
Collaborator
(none)
407
Enrollment
1
Location
84
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    407 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Jun 1, 2027
    Anticipated Study Completion Date :
    Jul 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing China

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: Yuankai Shi, Doctor, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shi Yuankai, chief physician, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT04491721
    Other Study ID Numbers:
    • NCC2288
    First Posted:
    Jul 29, 2020
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    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
    Keywords provided by Shi Yuankai, chief physician, Chinese Academy of Medical Sciences
    rituximab
    overall survival
    progression-free survival
    Additional relevant MeSH terms:
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Jul 29, 2020