A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

NCT04666038 Phase 3 ACTIVE_NOT_RECRUITING Results posted

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Details

Lead sponsor	Loxo Oncology, Inc.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	238
Start date	2021-03-09
Completion	2027-05

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

• Pirtobrutinib
• Idelalisib
• Bendamustine
• Rituximab

Primary outcomes

• Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) — Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)
  PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.

Countries

United States, Australia, Austria, Belgium, Canada, China, Croatia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom