NCT06530511

Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL

A Prospective, Single-arm, Multicenter Clinical Study of Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Patients with Frail Treatment-naive Non-germinal Center Subtype Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Polatuzumab vedotin	Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
DRUG	Rituximab	Rituximab: 375 mg/m2, IV Drip infusion, D1
DRUG	Orelabrutinib	Orelabrutinib: 150 mg/time, qd, po, D1-21

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2024-07-31
• Last updated: 2025-02-04

Locations

2 sites across 1 country: China