Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL.

ABSTRACT:

Background

Ibrutinib has been approved by the Food and Drug Administration for the treatment of patients with untreated chronic lymphocytic leukemia (CLL) since 2016 but has not been compared with chemoimmunotherapy. We conducted a phase 3 trial to evaluate the efficacy of ibrutinib, either alone or in combination with rituximab, relative to chemoimmunotherapy.

Methods

Patients 65 years of age or older who had untreated CLL were randomly assigned to receive bendamustine plus rituximab, ibrutinib, or ibrutinib plus rituximab. The primary end point was progression-free survival. The Alliance Data and Safety Monitoring Board made the decision to release the data after the protocol-specified efficacy threshold had been met.

Results

A total of 183 patients were assigned to

SUBMITTER: Woyach JA 

PROVIDER: S-EPMC6325637 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature