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December 8, 2025BloodOpen Access

Polatuzumab vedotin combined with orelabrutinib and rituximab (PRO Regimen) as frontline therapy in elderly and frail patients with diffuse large B-cell lymphoma (DLBCL): Results from A phase II study

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Authors

XXXiaoyan XieLCLei CaoYXYi Xia

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Overview

Phase II trial shows a 66.7% complete response and 90% progression-free survival in elderly DLBCL patients, highlighting safety of the PRO regimen.

Key Points

  • To evaluate the efficacy and safety of the PRO regimen in elderly and frail patients with DLBCL.
  • Single-arm, prospective Phase II study
  • Enrolled adults aged ≥80 or frail adults aged 60-79 with untreated DLBCL
  • Participants received Polatuzumab, Orelabrutinib, and Rituximab
  • Interim assessments via PET/CT or CT scans every three cycles
  • Primary endpoint was CR rate per Lugano 2014 criteria.
  • 25 patients enrolled with a median age of 80 years
  • CR rate of 66.7% (12/18), ORR of 94.5%
  • Estimated 6-month PFS was 90%
  • Common severe adverse events included pulmonary infections (20%)
  • All hematological toxicities were manageable with supportive care.

Cite This Study

Xie et al. (2025) studied this question.

synapsesocial.com/papers/69362f694fa91c937236deb2https://doi.org/10.1182/blood-2025-5477
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Pomalidomide, rituximab, and orelabrutinib in combination with polatuzumab vedotin for newly diagnosed diffuse large B-cell lymphoma in elderly, unfit, or frail patients:a prospective phase II study2025
  2. 2Efficacy and safety of the polatuzumab, acalabrutinib, rituximab, and lenalidomide (Pola-AR2) regimen as first-line therapy in unfit or frail patients with diffuse large B-cell lymphoma2025
  3. 3Clinical efficacy and safety of polatuzumab vedotin, rituximab, and zanubrutinib (POLA-Z-R) therapy in treatment of super-elderly patients with DLBCL: A real-world retrospective study2025
  4. 4Phase 2 Study of polatuzumab vedotin, zanubrutinib and rituximab (Pola-ZR) in untreated elderly and frail DLBCL patients: Molecular features and follow-up updates2025
  5. 5Real-world outcomes of polatuzumab, rituximab, and lenalidomide in frail pts with diffuse large B-cell lymphoma.2026