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RECRUITING
NCT06530511
PHASE2

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

Sponsor: Affiliated Hospital of Nantong University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-08-01

Completion Date

2026-08-01

Last Updated

2025-02-04

Healthy Volunteers

No

Interventions

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

Locations (2)

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Jiangsu Province Hospital

Nanjing, China