Title: Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (ASSURE)
Principal Investigator: Carsten Niemann, MD, Rigshospitalet, Denmark
Description: Researchers are conducting a phase 3B trial to evaluate the safety and efficacy of acalabrutinib (given at 100 mg twice per day) in patients with chronic lymphocytic leukemia (CLL).
Continue Reading
This is a single-arm, global study enrolling patients with treatment-naive CLL, those with relapsed or refractory disease, and those who had previous BTK inhibitor therapy. Participants will receive acalabrutinib until they complete 48 cycles (28 days per cycle), experience disease progression, or develop toxicity requiring discontinuation.
The primary outcome measure of this study is the number of participants with adverse events. Secondary outcome measures include objective response rate, duration of response, and progression-free survival.
To be eligible for this study, patients must have a diagnosis of CLL that meets the published diagnostic criteria. For a complete list of eligibility criteria, please refer to the reference.
Status: Recruiting
This study is sponsored by AstraZeneca in collaboration with Parexel.
Reference
ClinicalTrials.gov. Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (ASSURE). NCT04008706. Accessed August 18, 2021.
