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December 8, 2025BloodOpen Access

S2005: A phase II randomized study comparing ibrutinib and rituximab (IR) VS. venetoclax and rituximab (VR) in previously untreated waldenstrom's macroglobulinemia (WM) / lymphoplasmacytic lymphoma (LPL).

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Authors

ARAdam RosenthalJYJ Christine YeSUSaad Z. Usmani

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Overview

Randomized trial shows improved tolerability in untreated Waldenstrom's Macroglobulinemia patients receiving venetoclax compared to ibrutinib.

Key Points

  • This research aims to compare the effectiveness of ibrutinib plus rituximab versus venetoclax plus rituximab in treating Waldenstrom's Macroglobulinemia.
  • Conducted as a randomized phase II trial
  • Patients were randomized to ibrutinib plus rituximab or venetoclax plus rituximab
  • Enrolled patients had newly diagnosed WM with measurable disease
  • Treatment duration was for 2 years with observation after completion
  • Primary endpoint was the rate of very good partial response (VGPR)
  • Enrollment included 82 participants (41 per arm)
  • Current enrollment stands at 15 patients with anticipated accruals
  • Venetoclax demonstrated excellent activity in previous trials with a VGPR rate of 19%
  • The study seeks to determine improved outcomes without cardiac or hemostatic toxicity

Cite This Study

Rosenthal et al. (2025) studied this question.

synapsesocial.com/papers/693624d74fa91c937236d0b9https://doi.org/10.1182/blood-2025-1840
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Also Consider

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

  1. 1Final report of a phase II study of ibrutinib and venetoclax in previously untreated Waldenström macroglobulinemia2025 · 1 citations
  2. 2High VGPR/CR rates with pirtobrutinib plus venetoclax in previously treated Waldenström macroglobulinemia: Results from a multicenter phase II study2025 · 5 citations
  3. 3Final Report of a Phase <scp>II</scp> Study of Ibrutinib and Venetoclax in Previously Untreated Waldenström Macroglobulinemia2026
  4. 4BGB-11417-203: An ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia.2024 · 4 citations
  5. 5Venetoclax or pirtobrutinib in relapsed/refractory Waldenström macroglobulinemia: Clinical and molecular predictors and sequencing implications2025 · 2 citations