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July 9, 2025Leukemia & lymphoma/Leukemia and lymphomaOpen Access

Ibrutinib added to standard conditioning and as maintenance therapy following autologous hematopoietic stem cell transplantation for relapsed or refractory activated-B-cell type Diffuse Large B-cell lymphoma: primary analysis of the US intergroup double-blind randomized phase III study Alliance A051301/BMT-CTN 1201

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Authors

CACharalambos AndreadisUniversity of California, San FranciscoOBOlivia BobekMayo ClinicEHEric D. HsiMayo Clinic

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Overview

Randomized trial investigates 2-year progression free survival in ABC-DLBCL, suggesting improved outcomes with ibrutinib.

Key Points

  • The aim is to evaluate the impact of ibrutinib on 2-year progression free survival in relapsed or refractory ABC-DLBCL patients post-transplant.
  • Randomized phase 3 trial of ibrutinib 560 mg versus placebo for patients undergoing autologous hematopoietic stem cell transplantation.
  • Patients received either treatment with conditioning and continued for 12 additional cycles.
  • A total of 39 patients on ibrutinib and 38 on placebo were evaluable.
  • The 2-year progression free survival rate was 57.6% for the ibrutinib group compared to 40.8% for the placebo group (p = 0.09).
  • There was a higher incidence of grade ≥3 sepsis (10% vs 5%) and mucositis (13% vs 3%) in the ibrutinib group.
  • Four fatal adverse events due to infection occurred in the ibrutinib arm.

Cite This Study

Andreadis et al. (2025) studied this question.

synapsesocial.com/papers/6a5bfa1e9ba431813273da99https://doi.org/10.1080/10428194.2025.2525982
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Also Consider

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

  1. 1Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network2024 · 152 citations
  2. 2Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (TRIANGLE): 4·5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network.2026
  3. 3Follow-up from the A041202 study shows continued efficacy of ibrutinib regimens for older adults with CLL2024 · 50 citations
  4. 4Ibrutinib plus R-CHOP followed by maintenance in untreated ABC-DLBCL patients with IPI ≥2: A first analysis of phase II Study FIL_RI-CHOP2025
  5. 5Ibrutinib versus allogeneic haematopoietic stem cell transplant in relapsed/refractory del(17p) chronic lymphocytic leukaemia/small lymphocytic lymphoma2026