Clinical trial · Observational
Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab
Retrospective Observational Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab: a Subanalysis of the RTXM83-AC-01-11 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Group I
- description
- 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.
Primary outcomes (6)
- measure
- Effectiveness evaluation: subanalysis of event-free survival
- timeFrame
- 9 months after treatment
- description
- 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);
- measure
- Effectiveness evaluation: subanalysis of the Global Response Rate
- timeFrame
- At the end of Cycle 6 (each cycle is 03 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * not applicable
References
Publications (1)
- DERIVEDDelamain 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