Diffuse Large B Cell LymphomaNCT04928573
Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab
An observational study of Diffuse Large B Cell Lymphoma, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Feb 2022to 23 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Observational Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab: a Subanalysis of the RTXM83-AC-01-11 Trial
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.
Read the detailed description
Evaluate research participants who were refractory to treatment, defined as not having achieved: Complete Response (CR) or Partial Response (PR), after 6 treatment cycles in study RTXM83-AC-01-11.
Evaluate the participants who had a recurrence of the disease, defined as a change from: Complete Response (CR), after 06 treatment cycles in study RTXM83-AC-01-11, to: Progressive Disease (PD) until the date of consent (ICF) in the LB2002 study.
The data of the subsequent treatment / protocol instituted by the research center for progressive or recurrent disease will also be collected.
PERIOD OF ANALYSIS OF THIS CLINICAL STUDY
- 01-JUL-2013 (beginning of the study) to 17-JUL-2017 (data in which the last participant of the study RTXM83-AC-01-11 arrived at the last follow-up visit at 9 months after the last dose of treatment): for sub-analysis of efficacy and safety proposed by study RTXM83-AC-01-11: SLE, TRG and EA, and for exploratory evaluation of refractory disease.
- Data from randomization in study RTXM83-AC-01-11 to consent data (TCLE) in study LB2002: for analysis of SLP, SG and for exploratory evaluation of relapse.
- Date of the final visit of study RTXM83-AC-01-11, considered as FUP3, until the date of consent (ICF) in study LB2002: for the evaluation of late AEs of interest.
Data collect:For the subanalysis evaluations, the data that have already been collected will be used and are part of the study database RTXM83-AC-01-11. This database will also be considered for exploratory assessment of refractory disease.
For late evaluations of safety and efficacy (late adverse events of interest, SLP, SG and disease recurrence) and also data on the subsequent treatment / protocol instituted by the research center for progressive disease or disease recurrence, data from medical records available at research centers.
Finally, all the data necessary to evaluate the objectives established in this study will be imputed in a single Electronic Case Report Form (eCRF) developed exclusively for this project.
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- rituximab, Vivaxxia, Diffuse Large B Cell Lymphoma, biosimilar
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: 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);
Measured: 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);
Measured: 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;
Measured: 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;
Measured: 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.
Measured: From date of randomization until the date of death from any cause, assessed up to 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start8 Feb 2022
- Primary completion29 Jul 2022
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libbs Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928573
- Sponsor's protocol ID
- LB2002
- Status last verified
- Jul 2022
- First submitted
- 28 May 2021
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 38829416
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study for Late Assessment of the Safety and Efficacy of Biosimilar Rituximab: a Subanalysis of the RTXM83-AC-01-11 Trial
- ClinicalTrials.gov ID
- NCT04928573
- Acronym / sponsor ID
- LB2002
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- rituximab, Vivaxxia, Diffuse Large B Cell Lymphoma, biosimilar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Libbs Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evaluate research participants who were refractory to treatment, defined as not having achieved: Complete Response (CR) or Partial Response (PR), after 6 treatment cycles in study RTXM83-AC-01-11.
Evaluate the participants who had a recurrence of the disease, defined as a change from: Complete Response (CR), after 06 treatment cycles in study RTXM83-AC-01-11, to: Progressive Disease (PD) until the date of consent (ICF) in the LB2002 study.
The data of the subsequent treatment / protocol instituted by the research center for progressive or recurrent disease will also be collected.
PERIOD OF ANALYSIS OF THIS CLINICAL STUDY
- 01-JUL-2013 (beginning of the study) to 17-JUL-2017 (data in which the last participant of the study RTXM83-AC-01-11 arrived at the last follow-up visit at 9 months after the last dose of treatment): for sub-analysis of efficacy and safety proposed by study RTXM83-AC-01-11: SLE, TRG and EA, and for exploratory evaluation of refractory disease.
- Data from randomization in study RTXM83-AC-01-11 to consent data (TCLE) in study LB2002: for analysis of SLP, SG and for exploratory evaluation of relapse.
- Date of the final visit of study RTXM83-AC-01-11, considered as FUP3, until the date of consent (ICF) in study LB2002: for the evaluation of late AEs of interest.
Data collect:For the subanalysis evaluations, the data that have already been collected will be used and are part of the study database RTXM83-AC-01-11. This database will also be considered for exploratory assessment of refractory disease.
For late evaluations of safety and efficacy (late adverse events of interest, SLP, SG and disease recurrence) and also data on the subsequent treatment / protocol instituted by the research center for progressive disease or disease recurrence, data from medical records available at research centers.
Finally, all the data necessary to evaluate the objectives established in this study will be imputed in a single Electronic Case Report Form (eCRF) developed exclusively for this project.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness evaluation: subanalysis of event-free survival
Time frame: 9 months after treatment
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);
Effectiveness evaluation: subanalysis of the Global Response Rate
Time frame: At the end of Cycle 6 (each cycle is 03 weeks)
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);
Security evaluation: sub-analysis of the adverse events
Time frame: 9 months after treatment
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);
Effectiveness evaluation: progression-free survival
Time frame: 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
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;
Effectiveness evaluation: Assess the overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 96 months
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;
Security evaluation: occurrence of late adverse events
Time frame: From date of randomization until the date of death from any cause, assessed up to 96 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 38829416Delamain 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma, run by Libbs Farmacêutica LTDA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness evaluation: subanalysis of event-free survival (time frame: 9 months after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.