Ireland
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Recruiting Phase 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

NCT07908888 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-10-15
Last updated
2026-11-02

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

Polatuzumab Vedotin →Rituximab →Cyclophosphamide →Doxorubicin →Prednisone →

Polatuzumab Vedotin: Polatuzumab vedotin administered intravenously on Day 1 of each 21-day cycle for 6 induction cycles.

Rituximab: Rituximab administered intravenously on Day 1 of each 21-day cycle during induction and consolidation.

Cyclophosphamide: Reduced-dose cyclophosphamide administered intravenously on Day 2 of each 21-day cycle during induction.

Doxorubicin: Doxorubicin administered intravenously on Day 2 of each 21-day cycle during induction.

Prednisone: Prednisone administered orally on Days 2 to 6 of each 21-day cycle during induction.

Study 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 (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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL). 2. Age \>= 75 years; or age \>= 65 years with a G8 screening score \<= 14. 3. 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. 4. No prior systemic anti-tumor therapy for DLBCL, including chemotherapy, immunotherapy, targeted therapy or radiotherapy. 5. 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%. 6. Expected survival \>= 3 months. 7. The patient or their legal representative voluntarily participates in the study and signs the written informed consent form. Exclusion Criteria: 1. Prior anti-tumor therapy directed at DLBCL. 2. Bone marrow involvement or involvement of immune-privileged sites. 3. Concurrent other active malignancy, or a prior malignancy that in the investigator's judgment may affect the efficacy and safety evaluation of this study. 4. Currently participating in another interventional clinical study, or receiving other anti-tumor drug therapy that may affect the efficacy assessment of this study. 5. Uncontrolled active infection. 6. Severe cardiac, pulmonary, hepatic, renal or other major organ dysfunction that in the investigator's judgment precludes tolerance of the study treatment. 7. Other conditions considered unsuitable for enrollment by the investigator. 8. Patients eligible for transplantation.

Primary outcome measure(s)

  • 2-year progression-free survival (PFS) rate — 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.

Trial sites (1)

FacilityCityRegionStatus
The First Hospital of Jilin University Changchun Jilin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07908888 on ClinicalTrials.gov ↗ ← All trials in China