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A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study acronym: BRUIN-CLL-314
StatusRecruiting
PhasePhase 3
Started2022-07-22
View on ClinicalTrials.gov ↗

Amendment history

2026-08-14
Study Status, Contacts/Locations v46
Study sites143 entries, revised
Cancer Care Associates ofOf York
2026-07-16
Study Status, Contacts/Locations v45
Study sitesdetails revised at 1 of 143 sites
2026-06-16
Study Status, Contacts/Locations v44
Study sites144→143
2026-06-05
Study Status, Study Design, Arms and Interventions, Contacts/Locations v43
Enrollment increased: 662 → 737 participants
Primary completion pushed: 2025-06-10 → 2027-10
Study sitesdetails revised at 5 of 144 sites
2026-04-16
Study Status, Contacts/Locations v42
Study sitesdetails revised at 5 of 144 sites
Show 41 earlier versions
2026-03-31
Study Status, Contacts/Locations v41
Study sitesdetails revised at 5 of 144 sites
2026-03-11
Study Status, Contacts/Locations v40
Study sitesdetails revised at 5 of 144 sites
2026-02-13
Study Status, Contacts/Locations v39
Study sitesdetails revised at 3 of 144 sites
2026-02-09
Study Status v38
Re-verified, no change to tracked fields
2026-01-30
Study Status, Contacts/Locations v37
Study sitesdetails revised at 12 of 144 sites
2026-01-14
Study Status, Contacts/Locations v36
Study sites148→144
2026-01-12
Study Status, Contacts/Locations v35
Study sites144→148
2025-12-23
Study Status, Contacts/Locations v34
Study sitesdetails revised at 5 of 144 sites
2025-12-22
Study Status, Contacts/Locations v33
Study sites148→144
2025-12-16
Study Status v32
Re-verified, no change to tracked fields
2025-12-01
Study Status, Contacts/Locations v31
Study sitesdetails revised at 26 of 148 sites
2025-11-11
Study Status, Contacts/Locations v30
Study sitesdetails revised at 9 of 148 sites
2025-11-04
Study Status, Contacts/Locations v29
Study sitesdetails revised at 8 of 148 sites
2025-10-29
Study Status, Contacts/Locations v28
Study sitesdetails revised at 11 of 148 sites
2025-10-15
Study Status v27
Re-verified, no change to tracked fields
2025-10-08
Study Status, Contacts/Locations v26
Study sitesdetails revised at 1 of 148 sites
2025-09-25
Study Status, Contacts/Locations v25
Re-verified, no change to tracked fields
2025-09-08
Study Status, Contacts/Locations v24
Study sites177→148
2025-08-20
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v23
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 177 of 177 sites
2025-07-30
Study Status, Study Design v22
Enrollment targetestimated 725→confirmed 662
2025-07-15
Study Status v21
Primary completion dateestimated 2025-06→confirmed 2025-06-10
2025-06-05
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v20
Enrollment target650→725
Study arms2→3
Eligibility criteria+257 characters
Inclusion Criteria: Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing Eastern Cooperative Oncology Group (ECOG) Performance Status [...] istered study treatments Ongoing inflammatory bowel disease PriorPrevious treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent). Part 2: participants must be treatment naïve Concurrent use of investigational agent or anticancer therap [...]
Secondary endpoints6 to 9 entries
IRC-assessed Progression-Free Survival (PFS) Investigator assessed Progression-Free Survival (PFS) Comparative Tolerability Percentage of Participants Achieving DOR Part 2
Primary endpoints1 to 2 entries
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2 Percentage of Participants Achieving Complete Response (CR), [...] (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1
Collaborators-21 characters
Eli Lilly and Company
2025-04-17
2 amendments v18-v19
2 re-verifications since 2025-04-03, no change to tracked fields
2025-01-30
Study Status v17
Primary completion date2025-02→2025-06
Completion date2028-08→2028-01
2024-07-29
Recruiting→Active, Not Recruiting Study Status, Eligibility, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Eligibility criteria-1 characters
[...] Adequate organ function Platelets greater than or equal to (≥) 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with docu [...] lation with warfarin or another Vitamin K antagonist Use of ≥> 20 mg prednisone daily or equivalent dose of steroid at the [...]
Study sitesdetails revised at 177 of 177 sites
2024-05-10
Study Status, Contacts/Locations v15
Primary completion date2028-03-24→2025-02
Completion date2029-03-24→2028-08
Study sites204→177
2024-01-24
Study Status, Contacts/Locations v14
Study sites204 entries, revised
New YorkWestchester Medical CollegeCenter RhodeLifespan IslandCancer HospitalInstitute
2023-10-11
Study Status, Contacts/Locations v13
Study sites198→204
2023-07-10
Study Status, Arms and Interventions, Contacts/Locations v12
Study sites185→198
2023-04-12
Study Status, Outcome Measures, Eligibility, Contacts/Locations v11
Study sites77→185
Eligibility criteria+478 characters
[...] ion Platelets greater than or equal to (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, hemoglobin Hemoglobin ≥8 grams/deciliter (g/dL), andor absolute≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis Kidney function: Estimated creatinine clearance ≥30 millili [...] ocytopenic purpura [ITP]) Significant cardiovascular disease in [...] [...]
Secondary endpoints3 to 6 entries
Duration of Response (DOR) Overall Survival (OS) Time to worseningNext Treatment (TTNT) Time to Worsening (TTW) of CLL/SLL relatedRelated symptomsSymptoms
Primary endpoints1 entry, revised
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR)
2023-03-03
Study Status, Contacts/Locations v10
Study sites69→77
2023-02-16
Study Status, Contacts/Locations v9
Study sites65→69
2023-01-10
Study Status, Contacts/Locations v8
Study sites61→65
2022-12-15
Study Status, Contacts/Locations v7
Study sites37→61
2022-11-11
Study Status, Contacts/Locations v6
Study sites26→37
2022-10-11
Study Status, Contacts/Locations v5
Study sites1→26
2022-08-25
Study Status, Sponsor/Collaborators, References v4
Collaborators+21 characters
Eli Lilly and Company
2022-08-08
Study Status, Contacts/Locations v3
Study sites22→1
2022-08-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04→confirmed 2022-07-22
Study sites1→22
2022-04-19
Study Status, Study Design, Contacts/Locations v1
Primary completion date2028-03-01→2028-03-24
Completion date2029-03-01→2029-03-24
Start date2022-04-15→2022-04
Study sites0→1
2022-02-15
Original filing
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
Trial Details
NCT Number NCT05254743
Lead Sponsor Loxo Oncology, Inc.
Conditions Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma
Enrollment 737 participants
Start Date 2022-07-22
Primary Completion 2027-10 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-17