Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab

NCT04928573 | Completed

• 1 other identifier: LB2002
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The RTXM83-AC-01-11 study evaluated efficacy and safety outcomes in relation to the use of Vivaxxia during 6 treatment cycles (at the investigator's discretion, up to 8 treatment cycles could be administered), followed by 9 months of follow-up. , this follow-up time being sufficient for the analysis of non-inferiority in relation to the reference medicine. However, data on late events of efficacy and safety are of great value to contribute to a robust clinical response and to strengthen confidence in the use of biosimilar medicines. For this reason, Libbs Farmacêutica proposes this retrospective observational study to collect data on late outcomes of the pivotal study that directed the approval of the biosimilar rituximab (Vivaxxia) from the research participants from Brazil. The present retrospective observational study LB2002 will sub-analyze selected results of efficacy and safety from study RTXM83-AC-01-11 in participants over 18 years of age randomized in Brazil, totaling 28 participants, in addition to evaluating late efficacy and safety outcomes. Information on subsequent treatment / protocol should also be collected for participants who have progressive or recurrent disease, instituted by research centers under these conditions. The proposal is to compare descriptively the selected outcomes of efficacy and safety of these participants with the same outcomes selected for the global population in the RTXM83-AC-01-11 study, and also provide late safety and effective data important for anti-neoplastic processes.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

rituximab; Vivaxxia; Diffuse Large B Cell Lymphoma; biosimilar

Outcome Measures

Primary Outcomes (6)

• Effectiveness evaluation: subanalysis of event-free survival

  To present the subanalysis of event-free survival of participants from Brazil in the two treatment groups (RTXM83-CHOP and R-CHOP) from the randomization date until the final visit of the RTXM83-AC-01-11 study, considered as o FUP 3 (9-month follow-up after the end of treatment);

  9 months after treatment

• Effectiveness evaluation: subanalysis of the Global Response Rate

  To present the subanalysis of the Global Response Rate of participants from Brazil in the two treatment groups (RTXM83-CHOP and R-CHOP), after 6 treatment cycles in the RTXM83-AC-01-11 study, assessed as Complete Response ( RC) or Partial Response (PR);

  At the end of Cycle 6 (each cycle is 03 weeks)

• Security evaluation: sub-analysis of the adverse events

  Present the sub-analysis of the adverse events (AE) of the participants in Brazil that occurred from the date of signing the Free and Informed Consent Form (ICF) until the final visit of the study RTXM83-AC-01-11, considered as the FUP 3 (follow-up) 9 months after the end of treatment);

  9 months after treatment

• Effectiveness evaluation: progression-free survival

  Assess progression-free survival in the two treatment groups (RTXM83-CHOP and R-CHOP) from the date of randomization in the RTXM83-AC-01-11 study until the date of consent (ICF) in the LB2002 study;

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months

• Effectiveness evaluation: Assess the overall survival

  Assess the overall survival in the two treatment groups (RTXM83-CHOP and R-CHOP) from the date of randomization in study RTXM83-AC-01-11 until the date of consent (ICF) in study LB2002;

  From date of randomization until the date of death from any cause, assessed up to 96 months

• Security evaluation: occurrence of late adverse events

  Evaluate the occurrence of late adverse events of interest from the date of the final visit of the RTXM83-AC-01-11 study, considered as FUP 3, until the date of consent (TCLE) in the LB2002 study.

  From date of randomization until the date of death from any cause, assessed up to 96 months

Study Arms (1)

Group I

All participants previously randomized in Brazil for the phase III study RTXM83-AC-01-11 already completed, which was conducted to support the registration of the new biosimilar of rituximab (Vivaxxia) in different countries. The RTXM83-AC-01-11 study compared the efficacy and safety between biosimilar rituximab (RTXM83) and the reference rituximab (Mabthera®), both associated with CHOP chemotherapy (RTXM83-CHOP and R-CHOP, respectively) and included participants of the research with a diagnosis of lymphoma other than large B cell (LDGCB) CD20 positive.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants previously randomized in Brazil for the phase III study RTXM83-AC-01-11, already completed, will be eligible for this observational, retrospective study LB2002, which was conducted to support the registration of the new biosimilar of rituximab (Vivaxxia) in different countries. The RTXM83-AC-01-11 study compared the efficacy and safety between biosimilar rituximab (RTXM83) and reference rituximab (Mabthera®), both associated with CHOP chemotherapy (RTXM83-CHOP and R-CHOP, respectively) and included participants of the research with a diagnosis of diffuse large B cell lymphoma (LDGCB) CD20 positive.

You may qualify if:

• Free and informed consent to participate in this retrospective, observational study of data collection
• Research participants from Brazil randomized and who received at least one dose of treatment in the RTXM83-AC-01-11 study.

You may not qualify if:

• not applicable

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

Study Sites (1)

Dr Fernando Pericole

Campinas, São Paulo, 13083-878, Brazil

Location

Related Publications (1)

• Delamain MT, Cardoso ACF, Pericole FV, da Silva Araujo SS, Fogliatto L, Higashi M, Pereira J, da Silva RL, Werutsky G, de Paulo Giacon Radtke P, Salvino MA, Castilho V. Long-Term Safety and Effectiveness of Rituximab Biosimilar RTXM83: A Retrospective Extension Study in Brazilian Patients with Diffuse Large B-Cell Lymphoma. Oncol Ther. 2024 Sep;12(3):585-598. doi: 10.1007/s40487-024-00282-7. Epub 2024 Jun 3.

  PMID: 38829416 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 16, 2021
• Study Start: February 8, 2022
• Primary Completion: July 29, 2022
• Study Completion: March 23, 2023
• Last Updated: October 12, 2023

Record last verified: 2022-07

Locations

BR (1)