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. 2022 Oct;18(33):3689-3699.
doi: 10.2217/fon-2022-0456. Epub 2022 Sep 14.

MAJIC: a phase III trial of acalabrutinib + venetoclax versus venetoclax + obinutuzumab in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma

Christine E Ryan  1 , Matthew S Davids  1 , Richard Hermann  2 , Mina Shahkarami  2 , Juliana Biondo  3 , Sarang Abhyankar  3 , Hasan Alhasani  4 , Jeff P Sharman  5 , Anthony R Mato  6 , Lindsey E Roeker  6
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Free article

MAJIC: a phase III trial of acalabrutinib + venetoclax versus venetoclax + obinutuzumab in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma

Christine E Ryan et al. Future Oncol. 2022 Oct.
Free article

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] Future Oncol. 2023 Jan;19(3):271. doi: 10.2217/fon-2022-0456c1. Epub 2023 Jan 19. Future Oncol. 2023. PMID: 36655699 No abstract available.

Abstract

Here we describe the rationale and design of MAJIC, a phase III, prospective, multicenter, randomized trial comparing the combination of the BTK inhibitor acalabrutinib plus the BCL2 inhibitor venetoclax versus the combination of venetoclax plus obinutuzumab as frontline treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma. In both treatment arms, disease response (assessed by International Workshop on Chronic Lymphocytic Leukemia criteria) and minimal residual disease will be used to guide therapy duration, with all patients ultimately discontinuing treatment after a maximum of 2 years. The primary end point is progression-free survival. Key secondary end points include rates of undetectable minimal residual disease, overall response and overall survival. This study will address key unanswered questions in frontline chronic lymphocytic leukemia/small lymphocytic lymphoma therapy by investigating the optimal duration of finite treatment and identifying the optimal venetoclax doublet regimen.

Trial registration: ClinicalTrials.gov NCT05057494.

Keywords: CLL; MRD; SLL; acalabrutinib; finite therapy; frontline therapy; obinutuzumab; treatment-naïve; venetoclax.

Plain language summary

This article describes the design of the MAJIC clinical trial, which investigates two different treatment combinations for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received treatment for their disease previously. Patients will be randomized (put into a group by chance) to receive either acalabrutinib + venetoclax (AV) or venetoclax + obinutuzumab (VO). VO is already an approved initial treatment option for CLL/SLL. Acalabrutinib is also an approved initial treatment option when given by itself, but the AV combination is not yet approved. We are doing this study to better understand and directly compare how well AV and VO work when used for the treatment of CLL/SLL. A test done on the blood and bone marrow called ‘minimal residual disease’ will be used to help guide the length of time that patients receive treatment. Clinical Trial Registration: NCT05057494 (ClinicalTrials.gov).

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