A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Official Title

A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

Summary:

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Trial Description

Primary Outcome:

• To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)

• To evaluate the efficacy of Arm A compared to Arm B: Progression-free survival (PFS)
• To evaluate the efficacy of Arm A compared to Arm B: Overall survival (OS)
• To evaluate the efficacy of Arm A compared to Arm B: Time to next treatment (TTNT)
• To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS)
• To evaluate the efficacy of Arm A compared to Arm B: Overall response rate (ORR)
• To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
• To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning

View this trial on ClinicalTrials.gov