OncoMatch/Clinical Trials/NCT06530511

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

Is NCT06530511 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Polatuzumab vedotin and Rituximab for diffuse large b cell lymphoma.

Phase 2RecruitingAffiliated Hospital of Nantong UniversityNCT06530511Data as of May 2026

Treatment: Polatuzumab vedotin · Rituximab · Orelabrutinib — 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.

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Lab requirements

Blood counts

ANC < 1.5 x 10^9/L, PLT < 80 x 10^9/L, INR > 1.5 x ULN, PT and APTT > 1.5 x ULN (unless caused by Lymphoma)

Kidney function

Creatinine high 1.5 times the upper limit of normal, Creatinine clearance < 60 mL/min (unless caused by Lymphoma)

Liver function

ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal (unless caused by Lymphoma)

Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC < 1.5 x 10^9/L, PLT < 80 x 10^9/L b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d） Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance < 60 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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