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May 1, 2025Journal of Clinical OncologyOpen Access

Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma

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Authors

MWMichael WangMWMichael WangDBDavid Belada

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Overview

Randomized trial reveals improved progression-free survival with acalabrutinib and bendamustine-rituximab in untreated mantle cell lymphoma, indicating a potent first-line treatment option.

Key Points

  • To evaluate the efficacy and safety of adding acalabrutinib to bendamustine-rituximab as a first-line treatment regimen for older adults with untreated mantle cell lymphoma.
  • Randomized, double-blind trial assigning 598 previously untreated mantle cell lymphoma patients aged 65 years and older to acalabrutinib or placebo plus bendamustine-rituximab (N=299 per arm).
  • Patients received acalabrutinib (100 mg twice daily) or placebo alongside six cycles of bendamustine and rituximab, followed by two years of maintenance rituximab in responders with a median follow-up of 49.8 months.
  • Median progression-free survival was significantly prolonged with acalabrutinib compared to placebo (66.4 vs. 49.6 months; HR, 0.73 [95% CI, 0.57 to 0.94]; P = .0160).
  • Overall response and complete response rates were 91.0% and 66.6% in the acalabrutinib arm versus 88.0% and 53.5% in the placebo arm, while overall survival did not differ significantly (HR, 0.86 [95% CI, 0.65 to 1.13]; P = .27).
  • Grade 3 or greater adverse events occurred in 88.9% of patients in the acalabrutinib group and 88.2% in the placebo group.

Cite This Study

Wang et al. (2025) studied this question.

synapsesocial.com/papers/6a7154d435aa2c282ce2a361https://doi.org/10.1200/jco-25-00690
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Also Consider

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

  1. 1Safety and efficacy of acalabrutinib plus bendamustine and rituximab in patients with treatment-naive or relapsed / refractory mantle cell lymphoma: phase Ib trial2024 · 7 citations
  2. 2Efficacy of acalabrutinib in treatment-naive Mantle Cell Lymphoma: A systematic review and meta-analysis2025 · 1 citations
  3. 3Acalabrutinib in patients with mantle cell lymphoma subjected to allogeneic hematopoietic cell transplantation. a phase 2 study by the Polish Lymphoma Research Group (PLRG12 trial)2026
  4. 4Time to third-line treatment after bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: Updated analysis of the phase 3 ECHO trial after 50 months of follow-up2025 · 5 citations
  5. 5Phase 1/2 multicenter trial of acalabrutinib in Chinese patients with relapsed/refractory mantle cell lymphoma2024 · 3 citations