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<p>This phase 2 trial evaluated the safety and efficacy of acalabrutinib used to reduce tumor burden before allogeneic hematopoietic cell transplantation (allo-HCT) and as a maintenance therapy after transplantation in patients with relapsed/refractory mantle cell lymphoma (R/R MCL). Patients were treated with acalabrutinib 100&#xa0;mg BID for 3–6 months. Those achieving complete or partial response (CR, PR) were referred for allo-HCT. Acalabrutinib was restarted 30–90 days after allo-HCT and administered for the subsequent 9 months. The remaining patients continued acalabrutinib until progression or unacceptable toxicity. Out of the 28 included patients, 16 subjects (57%) responded, with CR in 14 cases (50%) and PR in 2 cases (7%). Fifteen patients (54%) underwent allo-HCT. Twenty-three patients (79%) had grade 3–4 adverse events, most commonly neutropenia (34%) and infections (21%). Five patients died of treatment-related toxicity, including infections in 4 cases. he probabilities of overall and progression-free survival (PFS) at 2 years were 60% (95%CI, 40–79) and 41.5% (23–60), respectively. PFS rate for patients treated with allo-HCT was 67% (44–92) at 18 months. Acalabrutinib generates high response rates in patients with R/R MCL and may serve as a “bridge” to allo-HCT and maintenance after transplantation. Infections are most frequent life-threatening complications.</p>

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Acalabrutinib in patients with mantle cell lymphoma subjected to allogeneic hematopoietic cell transplantation. a phase 2 study by the Polish Lymphoma Research Group (PLRG12 trial)

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  • 发表日期：

    2026年7月17日

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  • Sebastian Giebel,
  • Anna Czyż,
  • Iwona Hus,
  • Lidia Gil,
  • Krzysztof Giannopoulos,
  • Joanna Romejko-Jarosińska,
  • Maciej Majcherek,
  • Agnieszka Szeremet,
  • Anna Wache,
  • Paulina Kwaśnik,
  • Ryszard Swoboda,
  • Wojciech Jurczak

摘要

This phase 2 trial evaluated the safety and efficacy of acalabrutinib used to reduce tumor burden before allogeneic hematopoietic cell transplantation (allo-HCT) and as a maintenance therapy after transplantation in patients with relapsed/refractory mantle cell lymphoma (R/R MCL). Patients were treated with acalabrutinib 100 mg BID for 3–6 months. Those achieving complete or partial response (CR, PR) were referred for allo-HCT. Acalabrutinib was restarted 30–90 days after allo-HCT and administered for the subsequent 9 months. The remaining patients continued acalabrutinib until progression or unacceptable toxicity. Out of the 28 included patients, 16 subjects (57%) responded, with CR in 14 cases (50%) and PR in 2 cases (7%). Fifteen patients (54%) underwent allo-HCT. Twenty-three patients (79%) had grade 3–4 adverse events, most commonly neutropenia (34%) and infections (21%). Five patients died of treatment-related toxicity, including infections in 4 cases. he probabilities of overall and progression-free survival (PFS) at 2 years were 60% (95%CI, 40–79) and 41.5% (23–60), respectively. PFS rate for patients treated with allo-HCT was 67% (44–92) at 18 months. Acalabrutinib generates high response rates in patients with R/R MCL and may serve as a “bridge” to allo-HCT and maintenance after transplantation. Infections are most frequent life-threatening complications.