Trial reportAnnals of hematology2026
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).
Trial report in Annals of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
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.
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