Diffuse Large B-Cell LymphomaPhase 4NCT07908888
Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective Study
A Phase 4 study testing Polatuzumab Vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is a multicenter, single-arm, prospective study evaluating the efficacy and safety of polatuzumab vedotin and rituximab combined with a reduced-dose regimen of cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) as first-line treatment in elderly, frail patients with diffuse large B-cell lymphoma… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Polatuzumab Vedotin, Rituximab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 15 Aug 2029
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
- Age >= 75 years; or age >= 65 years with a G8 screening score <= 14.
- Assessed as "frail / poor tolerance" by geriatric assessment during screening, defined as meeting any one of the following: (a) G8 score <= 14; (b) IADL score <= 7; (c) >= 5 cumulative Grade 2 comorbidities on CIRS-G; (d) >= 1 system with a Grade 3-4 comorbidity on CIRS-G.
- No prior systemic anti-tumor therapy for DLBCL, including chemotherapy, immunotherapy, targeted therapy or radiotherapy.
- Adequate major organ function, defined as: (a) Hematologic: absolute neutrophil count (ANC) >= 1.0 x 10^9/L, platelets (PLT) >= 75 x 10^9/L; (b) Hepatic: AST and ALT <= 3 x upper limit of normal (ULN), total bilirubin <= 1.5 x ULN; (c) Renal: creatinine clearance (Ccr) >= 30 mL/min; (d) Cardiac: left ventricular ejection fraction (LVEF) within the institutional normal range by echocardiography, or LVEF >= 50%.
- Expected survival >= 3 months.
- The patient or their legal representative voluntarily participates in the study and signs the written informed consent form.
Who cannot join
- Prior anti-tumor therapy directed at DLBCL.
- Bone marrow involvement or involvement of immune-privileged sites.
- Concurrent other active malignancy, or a prior malignancy that in the investigator's judgment may affect the efficacy and safety evaluation of this study.
- Currently participating in another interventional clinical study, or receiving other anti-tumor drug therapy that may affect the efficacy assessment of this study.
- Uncontrolled active infection.
- Severe cardiac, pulmonary, hepatic, renal or other major organ dysfunction that in the investigator's judgment precludes tolerance of the study treatment.
- Other conditions considered unsuitable for enrollment by the investigator.
- Patients eligible for transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, 15804302602, baiou@jlu.edu.cn
About this study
This is a multicenter, single-arm, prospective study evaluating the efficacy and safety of polatuzumab vedotin and rituximab combined with a reduced-dose regimen of cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) as first-line treatment in elderly, frail patients with diffuse large B-cell lymphoma (DLBCL). The primary objective is to assess the 2-year progression-free survival (PFS) rate. Eligible participants are elderly patients with previously untreated DLBCL who are assessed as frail or with poor tolerance by comprehensive geriatric assessment.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
- 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.
Polatuzumab VedotinDrug
Polatuzumab vedotin administered intravenously on Day 1 of each 21-day cycle for 6 induction cycles.
RituximabDrug
Rituximab administered intravenously on Day 1 of each 21-day cycle during induction and consolidation.
CyclophosphamideDrug
Reduced-dose cyclophosphamide administered intravenously on Day 2 of each 21-day cycle during induction.
DoxorubicinDrug
Doxorubicin administered intravenously on Day 2 of each 21-day cycle during induction.
PrednisoneDrug
Prednisone administered orally on Days 2 to 6 of each 21-day cycle during induction.
| Study group | Role | What they receive |
|---|---|---|
| Pola-R-miniCHP | Experimental | Participants receive polatuzumab vedotin and rituximab combined with reduced-dose cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) for 6 cycles, followed by 2 cycles of rituximab consolidation. Each cycle is 21 days. Receives: Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival (PFS) rate
Progression-free survival rate at 2 years, defined as the proportion of participants alive and free of disease progression 2 years after the start of treatment. Progression is assessed according to the Lugano 2014 response criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2029 (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 LymphomaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908888
- Sponsor's protocol ID
- 26K229-001
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT07908888
- Acronym / sponsor ID
- 26K229-001
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 2 Nov 2026 (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.
This is a multicenter, single-arm, prospective study evaluating the efficacy and safety of polatuzumab vedotin and rituximab combined with a reduced-dose regimen of cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) as first-line treatment in elderly, frail patients with diffuse large B-cell lymphoma (DLBCL). The primary objective is to assess the 2-year progression-free survival (PFS) rate. Eligible participants are elderly patients with previously untreated DLBCL who are assessed as frail or with poor tolerance by comprehensive geriatric assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pola-R-miniCHP | Experimental | Drug: Polatuzumab Vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneParticipants receive polatuzumab vedotin and rituximab combined with reduced-dose cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) for 6 cycles, followed by 2 cycles of rituximab consolidation. Each cycle is 21 days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
- Age >= 75 years; or age >= 65 years with a G8 screening score <= 14.
- Assessed as "frail / poor tolerance" by geriatric assessment during screening, defined as meeting any one of the following: (a) G8 score <= 14; (b) IADL score <= 7; (c) >= 5 cumulative Grade 2 comorbidities on CIRS-G; (d) >= 1 system with a Grade 3-4 comorbidity on CIRS-G.
- No prior systemic anti-tumor therapy for DLBCL, including chemotherapy, immunotherapy, targeted therapy or radiotherapy.
- Adequate major organ function, defined as: (a) Hematologic: absolute neutrophil count (ANC) >= 1.0 x 10^9/L, platelets (PLT) >= 75 x 10^9/L; (b) Hepatic: AST and ALT <= 3 x upper limit of normal (ULN), total bilirubin <= 1.5 x ULN; (c) Renal: creatinine clearance (Ccr) >= 30 mL/min; (d) Cardiac: left ventricular ejection fraction (LVEF) within the institutional normal range by echocardiography, or LVEF >= 50%.
Key exclusion criteria (8 listed)
- Prior anti-tumor therapy directed at DLBCL.
- Bone marrow involvement or involvement of immune-privileged sites.
- Concurrent other active malignancy, or a prior malignancy that in the investigator's judgment may affect the efficacy and safety evaluation of this study.
- Currently participating in another interventional clinical study, or receiving other anti-tumor drug therapy that may affect the efficacy assessment of this study.
- Uncontrolled active infection.
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 |
|---|---|---|
| Polatuzumab VedotinPolatuzumab vedotin administered intravenously on Day 1 of each 21-day cycle for 6 induction cycles. | Drug | Pola-R-miniCHP |
| RituximabRituximab administered intravenously on Day 1 of each 21-day cycle during induction and consolidation. | Drug | Pola-R-miniCHP |
| CyclophosphamideReduced-dose cyclophosphamide administered intravenously on Day 2 of each 21-day cycle during induction. | Drug | Pola-R-miniCHP |
| DoxorubicinDoxorubicin administered intravenously on Day 2 of each 21-day cycle during induction. | Drug | Pola-R-miniCHP |
| PrednisonePrednisone administered orally on Days 2 to 6 of each 21-day cycle during induction. | Drug | Pola-R-miniCHP |
Primary outcome
2-year progression-free survival (PFS) rate
Time frame: 2 years
Progression-free survival rate at 2 years, defined as the proportion of participants alive and free of disease progression 2 years after the start of treatment. Progression is assessed according to the Lugano 2014 response criteria.
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 2 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polatuzumab Vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by The First Hospital of Jilin University at 1 site in China.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (PFS) rate (time frame: 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 2 Nov 2026.