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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)

Study acronym: BRUIN CLL-322
StatusActive, Not Recruiting
PhasePhase 3
Started2021-09-20
View on ClinicalTrials.gov ↗

Amendment history

2026-01-27
Study Status v29
Primary completion date2026-04→2026-10
Completion date2027-01→2027-10
2025-08-29
Study Status, Contacts/Locations v28
Study sitesdetails revised at 72 of 176 sites
2025-07-22
Study Status v27
Re-verified, no change to tracked fields
2025-07-01
Study Status, Contacts/Locations v26
Study sites177→176
2025-05-20
Study Status, Contacts/Locations v25
Study sites217→177
Show 24 earlier versions
2025-04-03
Study Identification, Study Status v24
Re-verified, no change to tracked fields
2024-11-15
Recruiting→Active, Not Recruiting Study Status, Outcome Measures, Contacts/Locations v23
Trial statusRecruiting→Active, Not Recruiting
Study sites218→217
Secondary endpoints7 entries, revised
To evaluate the effectivenessefficacy of Arm A compared to Arm B in patient-reported disease-related symptoms To evaluate the effectivenessefficacy of Arm A compared to Arm B in patient-reported physical functioning
2024-07-01
Study Status, Contacts/Locations v22
Study sites196→218
2024-05-10
Study Status v21
Primary completion date2025-10→2026-04
2024-01-24
Study Status, Contacts/Locations v20
Study sites191→196
2023-10-11
Study Status, Contacts/Locations v19
Study sites185→191
2023-09-12
Study Status, Contacts/Locations v18
Study sites148→185
2023-05-26
Study Status, Contacts/Locations v17
Study sites146→148
2023-03-03
Study Status, Contacts/Locations v16
Study sites146 entries, revised
Sunnybrook HealthResearch Sciences CentreInstitute
2023-02-15
Study Status, Contacts/Locations v15
Study sites145→146
2023-01-10
Study Status v14
Re-verified, no change to tracked fields
2022-12-15
Study Status, Contacts/Locations v13
Study sites140→145
2022-11-11
Study Status, Contacts/Locations v12
Study sites132→140
2022-10-11
Study Status, Contacts/Locations v11
Study sites123→132
2022-08-26
Study Status, Sponsor/Collaborators, Contacts/Locations, References v10
Study sites117→123
Collaborators+21 characters
Eli Lilly and Company
2022-06-27
Study Status, Contacts/Locations v9
Study sites108→117
2022-05-31
Study Status, Contacts/Locations v8
Study sites97→108
2022-04-27
Study Status, Contacts/Locations v7
Study sites92→97
2022-04-12
Study Status, Eligibility, Contacts/Locations v6
Eligibility criteria-47 characters
[...] ng cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors Prior therapy with venetoclax Central nervous system (CNS) [...]
2022-04-08
Study Status, Contacts/Locations v5
Study sites27→92
2021-11-16
Study Status, Contacts/Locations v4
Study sites10→27
2021-10-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-09→confirmed 2021-09-20
Study sites8→10
2021-09-09
Study Status, Contacts/Locations v2
Study sites2→8
2021-09-07
Study Status, Contacts/Locations v1
Start date2021-07→2021-09
Study sites0→2
2021-07-15
Original filing
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 Details
NCT Number NCT04965493
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 600 participants
Start Date 2021-09-20
Primary Completion 2026-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-29