Frontline acalabrutinib, lenalidomide and rituximab for advanced stage follicular lymphoma with high tumor burden: phase II trial

Paolo Strati (), Lei Feng, Jason R. Westin, Ranjit Nair, Luis E. Fayad, Maria A. Rodriguez, Dai Chihara, Luis Malpica, Jared Henderson, Mariana Gallardo, Marissa Rivera, Iris Wang, Anastasiia Bolshakova, Anastasia Radko, David Kurtz, Stefan K. Alig, Christopher R. Flowers, Ash A. Alizadeh and Sattva S. Neelapu
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Paolo Strati: The University of Texas MD Anderson Cancer Center
Lei Feng: The University of Texas MD Anderson Cancer Center
Jason R. Westin: The University of Texas MD Anderson Cancer Center
Ranjit Nair: The University of Texas MD Anderson Cancer Center
Luis E. Fayad: The University of Texas MD Anderson Cancer Center
Maria A. Rodriguez: The University of Texas MD Anderson Cancer Center
Dai Chihara: The University of Texas MD Anderson Cancer Center
Luis Malpica: The University of Texas MD Anderson Cancer Center
Jared Henderson: The University of Texas MD Anderson Cancer Center
Mariana Gallardo: The University of Texas MD Anderson Cancer Center
Marissa Rivera: The University of Texas MD Anderson Cancer Center
Iris Wang: BostonGene, Corp
Anastasiia Bolshakova: BostonGene, Corp
Anastasia Radko: BostonGene, Corp
David Kurtz: Foresight Diagnostics Inc
Stefan K. Alig: Ludwig-Maximilian-University (LMU) Hospital
Christopher R. Flowers: The University of Texas MD Anderson Cancer Center
Ash A. Alizadeh: Stanford University School of Medicine
Sattva S. Neelapu: The University of Texas MD Anderson Cancer Center

Nature Communications, 2025, vol. 16, issue 1, 1-10

Abstract: Abstract This phase II trial aims to determine the efficacy and safety of frontline acalabrutinib, lenalidomide and rituximab for patients with advanced stage follicular lymphoma (FL) and high tumor burden. The primary endpoint was best complete response (CR) rate; the secondary endpoints were overall response rate (ORR), duration of response measured as CR at 30 months (CR30), progression of disease at 24 months (POD24) rate, progression-free survival (PFS), overall survival and safety. Twenty-four patients with previously untreated FL were included in this phase 2 single arm study (NCT04404088). The most common grade 3-4 adverse events were neutropenia (58%) and liver function test elevation (17%). Best ORR was 100% and best CR rate was 92%. CR30 rate was 65% and POD24 rate was 17%. After a median follow-up of 43 months, median PFS and OS were not reached, 2-year PFS rate was 79% and 2-year OS rate was 92%. Here we show that the addition of acalabrutinib to R2 is a safe and effective frontline regimen for FL patients, and further exploration in larger clinical trials is needed.

Date: 2025
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DOI: 10.1038/s41467-025-62509-z

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