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. 2024 Jan 1;109(1):343-350.
doi: 10.3324/haematol.2022.282469.

Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors

Steven Le Gouill  1 , Monika Długosz-Danecka  2 , Simon Rule  3 , Pier Luigi Zinzani  4 , Andre Goy  5 , Stephen D Smith  6 , Jeanette K Doorduijn  7 , Carlos Panizo  8 , Bijal D Shah  9 , Andrew J Davies  10 , Richard Eek  11 , Eric Jacobsen  12 , Arnon P Kater  13 , Tadeusz Robak  14 , Preetesh Jain  15 , Roser Calvo  16 , Lin Tao  17 , Michael Wang  18
Affiliations

Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors

Steven Le Gouill et al. Haematologica. .
No abstract available

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Figures

Figure 1.
Figure 1.
Progression-free survival and overall survival in the total population (A, C) and in a subgroup of patients with blastoid and pleomorphic disease (B, D). A total of 59 out of 124 patients died (47.6%); causes include disease progression (N=40), adverse event (N=6 [1 patient experienced treatment-related myelodysplastic syndrome and died from pneumonia]), other cause (N=6), or unknown cause (N=7). Deaths due to “other cause” include secondary acute myeloid leukemia (N=2), lung cancer (N=1), pneumonia (N=1), intestinal obstruction (N=1), and graft-versus-host disease (N=1). Deaths due to “unknown cause” include a patient who died at home (N=1) and who had been qualified to next line of therapy (N=1). PFS: progression-free survival; CI: confidence interval; NE: not estimable; OS: overall survival.
Figure 2.
Figure 2.
Incidence of adverse events (AE) over time for grade ≥3 AE (A), any-grade serious AE (B), and any-grade select AE of interest (C; atrial fibrillation and major hemorrhage). A patient with multiple severity grades for a given AE was counted only once under the maximum severity. Multiple onsets of the same AE within a specific yearly interval were counted once, and the same AE term continuing across several yearly intervals was counted in each of the intervals; y: years.
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References

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    1. Wang ML, Rule S, Martin P, et al. . Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369(6):507-516. - PMC - PubMed
    1. Rule S, Dreyling M, Goy A, et al. . Outcomes in 370 patients with mantle cell lymphoma treated with ibrutinib: a pooled analysis from three open-label studies. Br J Haematol. 2017;179(3):430-438. - PMC - PubMed

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