Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

Summary

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PRIMARY OBJECTIVE: I. Measure the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy. SECONDARY OBJECTIVES: I. Evaluate the safety of this combination. II. Proportion proceeding to autologous stem cell transplant (ASCT). III. Feasibility and results o...

PRIMARY OBJECTIVE: I. Measure the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy. SECONDARY OBJECTIVES: I. Evaluate the safety of this combination. II. Proportion proceeding to autologous stem cell transplant (ASCT). III. Feasibility and results of stem cell mobilization and successful collection. IV. Progression-free survival (PFS) and overall survival (OS) (event monitoring phase), assessed up to 2 years after registration. CORRELATIVE RESEARCH OBJECTIVE: I. Assess minimal residual disease level after 3 and 6 cycles of therapy using the ClonoSEQ (Adaptive Biotechnologies, Seattle, Washington [WA]), and explore relationship with radiographic complete response (CR) rate and baseline features. OUTLINE: CYCLES 1, 3, AND 5: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-21. Patients also receive bortezomib subcutaneously (SC) on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) intravenously (IV), cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years after registration.

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