A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Leukemia/Myelodysplastic syndromes (MDS)/Myeloproliferative disorders (MPD), Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: III
Principal Investigator: Bociek, R Gregory
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03734016?cond=NCT03734016&draw=2&rank=1#eligibility
Summary
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Primary: 1. Overall response rate determined by independent review.
Secondary: 1. Progression-free survival determined y independent central review. 2. Progression-free survival determined by investigator assessment. 3. Duration of response determined by independent central review. 4. Duration of response determined by investigator assessment. 5. Time to treatment failure. 6. Overall survival. 7. Patient reported outcomes as assessed by EORTC-QLQ-C30. 8. Patient reported outcomes as assessed by EQ-5D-5L. 9. Incidence of adverse events as assessed by CTCAE v4.3 (Safety and Tolerability).