Sponsor: Alliance for Clinical Trials in Oncology
Sponsor Study ID: A052101
Study Title: A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma
CTO #: 104000
NCT Number: NCT05976763
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Non-Hodgkin's Lymphoma
Study Objectives: To compare time to first progression or death (PFS1) with continuous treatment (Arm A) and time to second progression or death (PFS2) with intermittent treatment that is restarted at first progression (Arm B). PFS1 and PFS2 will be defined as follows for patients who achieve complete remission (CR) with induction therapy and are randomized to a maintenance treatment arm: Continuous treatment Arm A: time from randomization until first progression or death from any cause (PFS1). Intermittent treatment Arm B: time from randomization until second progression or death from any cause (PFS2)