LymphomaNCT06790420
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
An observational study of Lymphoma, run by Pfizer at 1 site in Japan.
Trial summary
To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- What is being tested?
- Rituximab Pfizer and Rituxan
- How many people
- 2,703 participants
- Where
- 1 siteJapan
- Study dates
- 31 Jan 2025to 14 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The study population includes individuals who have a diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma and treated with Rituximab Pfizer and Rituxan
Who may be able to join
- Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
- Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
- Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
- Have not prescription of Rituximab product before index date(Comparative Analysis Set only).
Who cannot join
- 1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024
- Conditions
- Lymphoma
- Being tested
- Rituximab Pfizer, Rituxan
- Keywords
- Lymphoma, Rituximab, Infection
- Medical subject headings
- Lymphoma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab PfizerDrug
For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times
RituxanDrug
For the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | patients treated with Rituximab Pfizer Receives: Drug: Rituximab Pfizer | |
| Comparative group | patients treated with Rituxan Receives: Drug: Rituxan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Infections Which Requires Procedures, Medication or Hospitalization
Infection was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Secondary outcomes (7)
Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias)
Cytopenias were expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Infusion Reactions
Infusion reactions were expected to occur soon after the exposure. An incident event occurring during the period until the next day after the last dose was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which was until next day after last dose, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Hepatic Function Disorder (HFD), Jaundice
'HFD, Jaundice' were expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Cardiac Disorder
Cardiac disorder was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Gastrointestinal (GI) Perforation/Obstruction
GI perforation/obstruction was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Hypotension
Hypotension was expected to occur soon after the exposure. An incident event occurring during the period until the next day after the last dose was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of risk window which was until next day after last dose, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Development of Malignant Tumor
The observation of a latent outcome event like a malignancy required consideration that the 180-day risk window may not be sufficient. This study analyzed malignancy differently compared to the acute outcome events by extending follow-up time until the first incident event, death, end of the study period, or loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database). Additionally, two types of analyses based on propensity score were conducted.
Measured: From index date up to maximum of 5 years (the end of the study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start31 Jan 2025
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 2,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790420
- Sponsor's protocol ID
- B3281009
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2025
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
- ClinicalTrials.gov ID
- NCT06790420
- Acronym / sponsor ID
- B3281009
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Rituximab, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,703 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Rituximab Pfizerpatients treated with Rituximab Pfizer |
| Comparative group | – | Drug: Rituxanpatients treated with Rituxan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes individuals who have a diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma and treated with Rituximab Pfizer and Rituxan
Key inclusion criteria (4 listed)
- Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
- Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
- Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
- Have not prescription of Rituximab product before index date(Comparative Analysis Set only).
Key exclusion criteria (1 listed)
- 1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab PfizerFor the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times | Drug | Exposed group |
| RituxanFor the acute therapy, Rituximab is administrated once a week up to 8 times and for maintenance therapy, it is administrated every 8 weeks up to 12 times | Drug | Comparative group |
Primary outcome
Incidence of Infections Which Requires Procedures, Medication or Hospitalization
Time frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Infection was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
7 secondary outcomes
Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias)
Time frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Infusion Reactions
Time frame: From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Hepatic Function Disorder (HFD), Jaundice
Time frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Cardiac Disorder
Time frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Gastrointestinal (GI) Perforation/Obstruction
Time frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Hypotension
Time frame: From index date up to next day after last dose, with a maximum of 5 years (the end of the study period)
Incidence of Development of Malignant Tumor
Time frame: From index date up to maximum of 5 years (the end of the study period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Lymphoma, run by Pfizer at 1 site in Japan.
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 4 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 15 May 2026. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Infections Which Requires Procedures, Medication or Hospitalization (time frame: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026.