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Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study acronym: BRUIN CLL-321
StatusActive, Not Recruiting
PhasePhase 3
Started2021-03-09
View on ClinicalTrials.gov ↗

Amendment history

2026-04-07
3 amendments v33-v35
3 re-verifications since 2025-04-03, no change to tracked fields
2025-02-25
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v32
Results first postednot stated→2025-03-07
2025-01-13
Study Status, Outcome Measures (Results), Adverse Events v31
Re-verified, no change to tracked fields
2024-11-29
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v30
Enrollment targetestimated 250→confirmed 238
InterventionsBendamustine (Drug), Idelalisib (Drug), LOXO-305 (Drug), Rituximab (Drug)→Bendamustine (Drug), Idelalisib (Drug), Pirtobrutinib (Drug), Rituximab (Drug)
Secondary endpoints5 to 7 entries
ToPFS evaluateAssessed theby effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)Investigator To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS) To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT) Event Free Survival (EFS) Percentage of Participants With Overall Response Rate (ORR) Assessed by Investigator Time to worseningWorsening (TTW) of CLL/SLL relatedRelated symptomsSymptoms Time to worseningWorsening (TTW) of physicalPhysical functionFunction
Primary endpoints1 entry, revised
To evaluate progressionProgression-free survivalSurvival (PFS) ofAssessed LOXO-305by monotherapyIndependent Review Committee (Arm AIRC) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)
Study description-1 characters
[...] study. Eligible patients will be randomized in 1:1 to Arm A andor Arm B.
Study title+60 characters
Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (IdelaRIdelalisib Plus Rituximab or BRBendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
2024-10-25
Study Status v29
Re-verified, no change to tracked fields
Show 28 earlier versions
2024-07-23
Study Status v28
Primary completion date2023-11-01→2023-08-29
2024-04-24
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v27
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2023-11→confirmed 2023-11-01
Study sitesdetails revised at 232 of 232 sites
2023-10-30
Study Status v26
Primary completion date2023-10→2023-11
2023-10-25
Study Status v25
Primary completion date2023-12→2023-10
2023-06-28
Study Status, Contacts/Locations v24
Study sitesdetails revised at 212 of 232 sites
2023-05-04
Study Status, Contacts/Locations v23
Study sites227→232
2023-03-03
Study Status, Contacts/Locations v22
Study sites227 entries, revised
SamsungUniversity Medicalof Wisconsin Carbone Cancer Center
2023-02-15
Study Status, Contacts/Locations v21
Study sites226→227
2023-01-10
Study Status v20
Re-verified, no change to tracked fields
2023-01-04
Study Status, Study Design, Eligibility v19
Primary completion date2024-01→2023-12
Completion date2024-06→2027-05
Eligibility criteria+670 characters
Inclusion Criteria: Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria. Previously treated with a covalent BTK inhibitor. Eastern Cooperative Oncology Group (ECOG) 0-2. Absolute neutrophil count ≥ 0.75 × 10910^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement. Hemoglobin ≥ 8 g/dL notor requiring≥ transfusion6 g/dL in patients with document [...] [...]
2022-12-15
Study Status, Contacts/Locations v18
Study sites216→226
2022-11-11
Study Status, Contacts/Locations v17
Study sites209→216
2022-10-13
Study Status, Contacts/Locations v16
Study sites204→209
2022-08-30
Study Status, Contacts/Locations v15
Study sites201→204
2022-08-15
Study Status, Sponsor/Collaborators v14
Collaborators+21 characters
Eli Lilly and Company
2022-06-27
Study Status, Contacts/Locations v13
Study sites197→201
2022-06-01
Study Status, Contacts/Locations v12
Study sites190→197
2022-04-27
Study Status, Contacts/Locations v11
Study sites187→190
2022-04-19
Study Status, Contacts/Locations v10
Re-verified, no change to tracked fields
2022-04-11
Study Status, Contacts/Locations v9
Study sites123→187
2022-01-27
Study Identification, Study Status, Contacts/Locations v8
Study sites75→123
Study title+76 characters
Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small orLymphocytic Lymphoma (SLL)
2021-10-08
Study Status, Contacts/Locations v7
Study sites57→75
2021-09-17
Study Status, Contacts/Locations v6
Study sites31→57
2021-06-24
Study Status, Contacts/Locations v5
Study sites75→31
2021-06-07
Study Status, Contacts/Locations v4
Study sites55→75
2021-04-30
Study Status, Contacts/Locations v3
Study sites2→55
2021-04-01
Not Yet Recruiting→Recruiting Study Identification, Study Status, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-02→confirmed 2021-03-09
Study sites0→2
Eligibility criteria+80 characters
[...] Richter's transformation at any time preceding enrollment. Known or suspected history of central nervous system (CNS) involvement by CLL/SLL Ongoing drug-induced liver injury Active uncontrolled auto-immune cytopenia Significant cardiovascular disease. History of allogeneic or stem cell transplantation (SCT) or [...] tor-modified T cells (CAR-T) therapy within the past 60 days. Active hepatitis B or hepatitis C Known active cytomegalovi [...]
2021-02-10
Study Status, Outcome Measures, Eligibility v1
Start date2021-01→2021-02
Eligibility criteria+23 characters
[...] K antagonist. Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors Vaccination with a live vaccine within 28 days p [...]
Secondary endpointsdetails revised at 1 of 5 entries
2020-12-07
Original filing
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.
Trial Details
NCT Number NCT04666038
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 238 participants
Start Date 2021-03-09
Primary Completion 2023-08-29 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-24