Lymphoma

A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)

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.

Key Eligibility 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
• Any evidence of diseases that would make the study undesirable for the patient or that would impact compliance with the protocol excluded
• History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results excluded