RecruitingPhase 2NCT06530511

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


Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — polatuzumab vedotin, rituximab, and orelabrutinib — for elderly or frail patients who have never been treated for a specific type of aggressive blood cancer called non-GCB diffuse large B-cell lymphoma (DLBCL). The regimen is designed to be effective but gentler than standard chemotherapy. **You may be eligible if...** - You are 60 years or older and have been assessed as frail or unfit for standard chemotherapy (via a geriatric assessment) - You have been newly diagnosed with non-GCB DLBCL (confirmed by biopsy) - You have measurable disease on imaging - You have not previously received lymphoma treatment (except corticosteroids) **You may NOT be eligible if...** - You have already received chemotherapy or other lymphoma treatments - Your DLBCL is the germinal center (GCB) subtype - You are fit enough for standard R-CHOP chemotherapy - You have serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolatuzumab vedotin

Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;

DRUGRituximab

Rituximab: 375 mg/m2, IV Drip infusion, D1

DRUGOrelabrutinib

Orelabrutinib: 150 mg/time, qd, po, D1-21


Locations(2)

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Jiangsu Province Hospital

Nanjing, China

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NCT06530511


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