A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: III
Principal Investigator: Vose, Julie
Contact Information:
Jeanne Welte
jewelte@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04662255?term=NCT04662255&rank=1
Summary
Primary
To compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
Secondary
To compare efficacy of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
To evaluate the safety and tolerability of each treatment arm
To evaluate the patient-reported outcomes