Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Trial Parameters
Brief Summary
The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.
Eligibility Criteria
Inclusion Criteria: * ≥ 80 years of age at the time of screening, or * ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy * Histologically documented DLBCL * No prior treatment for DLBCL * Stage II, III, or IV disease by the Ann Arbor Classification . * Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma. * At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements. * Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening. Exclusion Criteria: * Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding di