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)
AstraZeneca
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.
Description
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm. Study details include the following: * The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up. * The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.
Eligibility
- Age range
- 65–99 years
- Sex
- All
- Healthy volunteers
- No
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 diamete…
Interventions
- DrugAcalabrutinib
Patients will receive acalabrutinib orally with dosing schedule of X.
- BiologicalRituximab
Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8.
Locations (57)
- Research SiteBerkeley, California
- Research SiteLa Jolla, California
- Research SiteOrange, California
- Research SiteStamford, Connecticut
- Research SiteJacksonville, Florida
- Research SiteDes Moines, Iowa