Dr. Robak on the Inclusion Criteria of the RESONATE-2 Trial in CLL

Tadeusz Robak, MD, PhD, professor of hematology, Medical University of Lodz, chief, Department of Hematology, Copernicus Memorial Hospital, Lodz, Poland, discusses the inclusion criteria of the the phase 3 RESONATE-2 trial (NCT01722487) in chronic lymphocytic leukemia (CLL).

With up to 7 years of follow-up, findings from the RESONATE-2 trial demonstrated sustained progression-free survival and overall survival benefit with frontline, single-agent ibrutinib (Imbruvica) vs chlorambucil in patients with CLL. 

This study enrolled patients with previously untreated CLL, Robak explains. Major inclusion criteria stated that patients had to be at least 65 years of age, Robak explains. Patients were randomized 1:1 to receive ibrutinib vs chlorambucil.

Moreover, patients with 17p deletions were excluded from the study. At the time the study was planned, chlorambucil was a standard frontline therapy for patients with CLL, Robak explains. However, it was known that chlorambucil was was not an acceptable therapy for patients who harbored 17p deletions, Robak concludes.