Polatuzumab Vedotin, Mosunetuzumab, and Acalabrutinib for the Treatment of Mantle Cell Lymphoma, PAcMan Trial

OUTLINE: INDUCTION: Patients receive polatuzumab vedotin intravenously (IV) over 30-90 minutes on day 1 of cycles 1-6, mosunetuzumab subcutaneously (SC) on days 1, 8, and 15 of cycle 1 and on day 1 of cycles 2-17, and acalabrutinib orally (PO) twice daily (BID) on days 1-21 of cycles 1-17. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve less than partial response (PR) discontinue study. Standard risk patients who achieve CR proceed to surveillance. Responding high-risk patients and responding standard risk patients who fail to achieve CR proceed to maintenance. MAINTENANCE: Patients receive mosunetuzumab SC on day 1 of each cycle and acalabrutinib PO BID on days 1-56 of each cycle. Cycles repeat every 56 days for up to 12 cycles (cycles 18-29) in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples, fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT), and core biopsy (optional) throughout the trial and undergo bone marrow aspiration (BMA) and bone marrow biopsy (BMB) at screening (optional) and on study. After completion of study treatment, patients are followed for up to 5 years.