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 (BRUIN CLL-313)

NCT05023980 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Loxo Oncology, Inc.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	309
Start date	2021-09-23
Completion	2027-10

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

• Pirtobrutinib
• Bendamustine
• Rituximab

Primary outcomes

• To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) — Up to approximately 5 years
  Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

Countries

United States, Australia, Austria, Brazil, Bulgaria, China, Czechia, France, Hungary, Italy, Japan, New Zealand, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom