Diffuse Large B Cell Lymphoma (DLBCL)NCT07310186
Treatment and Outcomes of DLBCL After Progression on Polatuzumab Vedotin-based Combination Therapy
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by Peking Union Medical College Hospital.
Trial summary
Diffuse Large B-cell Lymphoma (DLBCL) is a common hematologic malignancy. Even after standard first-line treatment, approximately 40% of patients will experience relapse. Currently, polatuzumab vedotin (pola) has been incorporated into DLBCL treatment (both for newly diagnosed and relapsed cases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- observational study
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200
Who may be able to join
- Patients diagnosed with DLBCL
- Age ≥18 years
- Prior treatment with a polatuzumab vedotin (pola)-containing regimen and confirmed disease progression (refractory/relapsed) after this therapy.
- Availability of complete electronic medical records and ability to be contacted via telephone.
- Full understanding of the study, voluntary participation, and willingness to sign the informed consent form.
Who cannot join
- Patients who have not received pola-based regimen treatment.
- Incomplete electronic medical records or unreachable by telephone.
About this study
Official title: Salvage Treatment Strategies and Clinical Outcomes in Diffuse Large B-cell Lymphoma After Failure of Polatuzumab Vedotin-based Combination Therapy: A Multi-center, Retro- and Prospective, Observational, Real-World Study
Diffuse Large B-cell Lymphoma (DLBCL) is a common hematologic malignancy. Even after standard first-line treatment, approximately 40% of patients will experience relapse. Currently, polatuzumab vedotin (pola) has been incorporated into DLBCL treatment (both for newly diagnosed and relapsed cases). However, for patients whose disease progresses after pola-containing regimens, the subsequent treatment options, efficacy, and survival outcomes remain unclear. Understanding these real-world scenarios is of great significance, as it can guide clinicians in developing better and more tailored treatment strategies for patients in the future.
Therefore, we plan to conduct this real-world study titled "Salvage Treatment Strategies and Clinical Outcomes in Diffuse Large B-cell Lymphoma After Failure of Polatuzumab Vedotin-based Combination Therapy", aiming to obtain real-world data from the Chinese population.
Read the detailed description
This is a retro- and prospective, observational study
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- observational study
- Keywords
- DLBCL, polatuzumab vedotin, Salvage Treatment
- 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.
observational studyOther
this is an observational study, we do not interfere with treatment strategies
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
the ratio of patients achieves complete response
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310186
- Sponsor's protocol ID
- PUMCH-NHL-022
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Treatment Strategies and Clinical Outcomes in Diffuse Large B-cell Lymphoma After Failure of Polatuzumab Vedotin-based Combination Therapy: A Multi-center, Retro- and Prospective, Observational, Real-World Study
- ClinicalTrials.gov ID
- NCT07310186
- Acronym / sponsor ID
- PUMCH-NHL-022
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- DLBCL, polatuzumab vedotin, Salvage Treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Dec 2025 (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.
Diffuse Large B-cell Lymphoma (DLBCL) is a common hematologic malignancy. Even after standard first-line treatment, approximately 40% of patients will experience relapse. Currently, polatuzumab vedotin (pola) has been incorporated into DLBCL treatment (both for newly diagnosed and relapsed cases). However, for patients whose disease progresses after pola-containing regimens, the subsequent treatment options, efficacy, and survival outcomes remain unclear. Understanding these real-world scenarios is of great significance, as it can guide clinicians in developing better and more tailored treatment strategies for patients in the future.
Therefore, we plan to conduct this real-world study titled "Salvage Treatment Strategies and Clinical Outcomes in Diffuse Large B-cell Lymphoma After Failure of Polatuzumab Vedotin-based Combination Therapy", aiming to obtain real-world data from the Chinese population.
Detailed description
This is a retro- and prospective, observational study
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200
Key inclusion criteria (5 listed)
- Patients diagnosed with DLBCL
- Age ≥18 years
- Prior treatment with a polatuzumab vedotin (pola)-containing regimen and confirmed disease progression (refractory/relapsed) after this therapy.
- Availability of complete electronic medical records and ability to be contacted via telephone.
- Full understanding of the study, voluntary participation, and willingness to sign the informed consent form.
Key exclusion criteria (2 listed)
- Patients who have not received pola-based regimen treatment.
- Incomplete electronic medical records or unreachable by telephone.
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 |
|---|---|---|
| observational studythis is an observational study, we do not interfere with treatment strategies | Other | – |
Primary outcome
complete response rate
Time frame: through study completion, an average of 2 years
the ratio of patients achieves complete response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by Peking Union Medical College Hospital.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
complete response rate (time frame: through study completion, an average of 2 years). 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 30 Dec 2025.