NCT07908888RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 15 Aug 2029
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07908888
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 26
- From 15 Oct 2026 to the primary completion date, 15 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-tumor therapy directed at DLBCL.
- Currently participating in another interventional clinical study, or receiving other anti-tumor drug therapy that may affect the efficacy assessment of this study.
- Patients eligible for transplantation.
Other illness
- Concurrent other active malignancy, or a prior malignancy that in the investigator's judgment may affect the efficacy and safety evaluation 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.
Other
- Bone marrow involvement or involvement of immune-privileged sites.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.