A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Inclusion Criteria:
Exclusion Criteria:
Known or suspected Richter's transformation at any time preceding enrollment
Prior systemic therapy for CLL/SLL
Presence of 17p deletion
Central nervous system (CNS) involvement
Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
Significant cardiovascular disease
Active hepatitis B or hepatitis C
Active cytomegalovirus (CMV) infection
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Concurrent use of investigational agent or anticancer therapy except hormonal therapy
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Vaccination with a live vaccine within 28 days prior to randomization
Patients with the following hypersensitivity:
Porto Alegre, Rio Grande do Sul 90050-170, Brazil
Wuhan, Hubei 430022, China
Shenyany, Liaoning 110022, China
Changning District, Shanghai Municipality 200050, China
Yoshida-Gun, Fukui 910-1193, Japan
Fukoka-ken, 806 8501, Japan
Iwaszkiewicza 5, Legnica 59-220, Poland
Warsaw, 02781, Poland
Saint Petersburg, 197022, Russia
Namdong-gu, Incheon-gwangyeoksi [Incheon] 21565, South Korea
Seocho-Gu, Seoul 06591, South Korea
Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea