A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma

Dreyling, M; Tam, CS; Wang, M; Smith, SD; Ladetto, M; Huang, H; Novotny, W; Co, M; Romano, A; Holmgren, E; Huang, J; Le Gouill, S

Author(s): Dreyling, M; Tam, CS; Wang, M; Smith, SD; Ladetto, M; Huang, H; Novotny, W; Co, M; Romano, A; Holmgren, E; Huang, J; Le Gouill, S;
Details: Publication Year 2021-01,Volume 17,Issue #3,Page 255-262
Journal Title: Future Oncology
Publication Type: Protocol
Abstract: Mantle cell lymphoma is an aggressive B-cell malignancy. Current frontline chemoimmunotherapies produce high response rates but relapse is inevitable. Furthermore, the elderly and those with comorbidities are precluded from standard regimens and stem cell transplant, leaving them with limited options. Targeted therapies, including Bruton tyrosine kinase inhibitors, are an effective treatment strategy in mantle cell lymphoma. Zanubrutinib is a potent next-generation Bruton tyrosine kinase inhibitor that has demonstrated complete and sustained Bruton tyrosine kinase occupancy, minimal off-target effects and favorable pharmacokinetic/pharmacodynamic properties. Described herein is an ongoing Phase III study comparing the efficacy and safety of zanubrutinib plus rituximab followed by zanubrutinib monotherapy versus bendamustine plus rituximab followed by observation in transplant-ineligible patients with previously untreated mantle cell lymphoma. Clinical Trial Registration: NCT04002297 (ClinicalTrials.gov).
Keywords: Agammaglobulinaemia Tyrosine Kinase/*antagonists & inhibitors; Aged; Antineoplastic Agents, Alkylating/therapeutic use; Antineoplastic Agents, Immunological/therapeutic use; Antineoplastic Combined Chemotherapy Protocols/*therapeutic use; Bendamustine Hydrochloride/therapeutic use; Drug Resistance, Neoplasm; Humans; Lymphoma, Mantle-Cell/*drug therapy/mortality/pathology; Piperidines/*therapeutic use; Progression-Free Survival; Protein Kinase Inhibitors/*therapeutic use; Pyrazoles/*therapeutic use; Pyrimidines/*therapeutic use; Recurrence; Rituximab/therapeutic use; Safety; Survival Rate; Treatment Outcome; BTK inhibitor; Bruton tyrosine kinase; clinical trial; mantle cell lymphoma; zanubrutinib
Department(s): Haematology
PubMed ID: 32985902
Publisher's Version: https://doi.org/10.2217/fon-2020-0794
Open Access at Publisher's Site: https://doi.org/10.2217/fon-2020-0794
Terms of Use/Rights Notice: Refer to copyright notice on published article.

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Last Modified: 2026-07-03 05:54:48