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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | Recruiting |
More The First Hospital of Jilin University trials in China
Other trials for the same condition
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