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Leo I. Gordon, MD, FACP


Adding Acalabrutinib to Combination Therapy for Mantle Cell Lymphoma

By: Vanessa A. Carter, BS
Posted: Friday, January 13, 2023

Jia Ruan, MD, PhD, of Meyer Cancer Center, Weill Cornell Medicine, and New York Presbyterian Hospital, and colleagues assessed adding the next-generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib to combination therapy with lenalidomide and rituximab in patients with treatment-naive mantle cell lymphoma. Their preliminary findings with this triplet combination were presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 73).

“This study demonstrates that triple chemotherapy-free combination [is] well tolerated, highly effective, and produces high rates of measurable residual disease [MRD]-negative complete response as initial treatment for mantle cell lymphoma, including high-risk patients with TP53 mutations,” concluded the investigators. “Real-time MRD analysis facilitates response-adapted treatment de-escalation during maintenance to minimize toxicity, which warrants further evaluation.”

A total of 24 patients with previously untreated mantle cell lymphoma received 100 mg of acalabrutinib twice per day plus 15 mg of lenalidomide on days 1 to 21 of a 28-day cycle for 12 cycles. Participants also received weekly rituximab during cycle 1, followed by once every other cycle throughout induction and maintenance.

At the median follow-up of 19 months, 21 patients completed 12 induction cycles, and 11 patients completed 24 cycles of treatment. After 12 treatment cycles, the overall response rate was 100%, and the rate of complete response was 90.5%. Of note, MRD was undetectable in 50% of patients after 6 cycles, in 71% after 12 cycles, and in 82% after 24 cycles. To date, seven patients who achieved an MRD-negative complete response have discontinued acalabrutinib and lenalidomide.

Hematologic toxicities of grade 3 or 4 included neutropenia, thrombocytopenia, and anemia. Common grade 3 or 4 nonhematologic toxicities were rash, nausea, hyponatremia, and fatigue; routine infections also occurred. During the “Omicron wave,” 16 patients developed a COVID-19 infection, and 6 patients experienced grade 3 COVID-19 pneumonia. There were four incidences of a second malignancy, including renal cell carcinoma and nonmelanoma skin cancer.

Disclosure: For full disclosures of the study authors, visit

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