Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05023980 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study acronym: BRUIN-CLL-313
StatusActive, Not Recruiting
PhasePhase 3
Started2021-09-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Loxo Oncology, Inc.

Amendment history

2026-09-26
Primary endpoint(s) modified1 entry, revised
WasTo evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
NowArm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Results posted: 2026-09-25
2026-07-09
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v25
Enrollment target309→282
Secondary endpoints7 to 9 entries
Progression-free Survival (PFS), Assessed by Investigator To evaluateEvaluate the effectivenessEffectiveness of Arm A compared to Arm B: Progression-free survival (PFS) To evaluate the effectiveness of Arm A comparedCompared to Arm B: Overall survivalSurvival (OS) To evaluate the effectiveness of Arm A compared to Arm B: Time to nextNext treatmentTreatment (TTNT), Assessed by Investigator To evaluate the effectivenessPercentage of ArmParticipants A compared to Arm B:With Overall response rateResponse (ORR), Assessed by IRC To evaluate the effectivenessPercentage of ArmParticipants AWith compar [...] [...]
Primary endpoints1 entry, revised
To evaluate progressionProgression-free survivalSurvival (PFS), ofAssessed pirtobrutinibby Independent Review Committee (Arm AIRC) compared to bendamustine and rituximab (Arm B)
2026-01-21
Study Status v24
Completion date2026-08→2027-10
2025-07-22
Study Status, Study Design v23
Enrollment targetestimated 250→confirmed 309
2025-07-15
Study Status v22
Primary completion dateestimated 2025-07→confirmed 2025-07-11
Show 21 earlier versions
2025-06-03
Study Status v21
Primary completion date2025-05→2025-07
2025-04-24
2 amendments v19-v20
2 re-verifications since 2025-04-03, no change to tracked fields
2025-03-13
Study Status v18
Primary completion date2025-04→2025-05
2025-01-30
Study Status, Contacts/Locations v17
Primary completion date2025-01→2025-04
Completion date2026-05→2026-08
2024-06-27
Study Status, Contacts/Locations v16
Study sites146→108
2024-04-04
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-11→2025-01
Completion date2026-07→2026-05
Study sitesdetails revised at 146 of 146 sites
2023-07-08
Study Status, Contacts/Locations v14
Study sitesdetails revised at 127 of 146 sites
2023-03-03
Study Status, Contacts/Locations v13
Study sitescontacts updated at 2 of 146 sites
2023-02-15
Study Status, Contacts/Locations v12
Study sites143→146
2023-01-10
Study Status, Contacts/Locations v11
Study sites142→143
2022-12-14
Study Status, Contacts/Locations v10
Study sites128→142
2022-11-11
Study Status, Contacts/Locations v9
Study sites119→128
2022-10-12
Study Status, Contacts/Locations v8
Study sites108→119
2022-08-25
Study Status, Sponsor/Collaborators, Contacts/Locations, References v7
Study sites89→108
Collaborators+21 characters
Eli Lilly and Company
2022-07-04
Study Status, Contacts/Locations v6
Study sites69→89
2022-05-02
Study Status, Contacts/Locations v5
Study sites41→69
2022-03-11
Study Status, Contacts/Locations v4
Study sites3→41
2021-11-10
Study Status, Contacts/Locations v3
Study sites1→3
2021-10-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-09→confirmed 2021-09-23
Study sitesdetails revised at 1 of 1 site
2021-09-08
Study Status, Contacts/Locations v1
Study sites0→1
2021-08-24
Original filing
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Trial Details
NCT Number NCT05023980
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 282 participants
Start Date 2021-09-23
Primary Completion 2025-07-11 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-25