NCT07001540

Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation

Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous transplantation.

Detailed description

This prospective, multicenter, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of Pola-R-GemOx in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are unsuitable for autologous transplantation. The study aims to enroll 130 patients, all of whom will initially receive three cycles of Pola-R-GemOx. Subsequent treatment decisions will be based on therapeutic efficacy and transplant assessment. ① Patients achieving complete response (CR) or partial response (PR) after three cycles will proceed with an additional three cycles. Those achieving CR following six cycles will conclude treatment, while all other patients will transition to subsequent-line therapy. ② Patients who do not achieve CR or PR after three cycles will discontinue the regimen and proceed directly to subsequent-line therapy. The primary endpoint of the trial is the investigator-assessed objective response rate (ORR). Secondary endpoints include other efficacy measures, such as complete response rate (CR), event-free survival (EFS), 24-month progression-free survival (PFS) rate, overall survival (OS), and safety outcomes. Additionally, exploratory analyses will be conducted to identify potential predictors of clinical efficacy and safety.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)	Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx)

Timeline

• Start date: 2025-05-08
• Primary completion: 2027-11-15
• Completion: 2027-11-15
• First posted: 2025-06-03
• Last updated: 2025-06-19

Locations

1 site across 1 country: China