Polatuzumab vedotin with lower-dose chemotherapy for frail older adults with diffuse large B-cell lymphoma

Trial details

Who runs it

The First Hospital of Jilin University

Trial code

NCT07908888

Record updated

2 November 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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; 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; Bone marrow involvement or involvement of immune-privileged sites.

ClinicalTrials.gov NCT07908888