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A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

StatusRecruiting
PhasePhase 2
Started2025-01-03
View on ClinicalTrials.gov ↗

Amendment history

2026-05-18
Study Status, Contacts/Locations v19
Study sites132→131
2026-05-11
Study Status, Contacts/Locations v18
Study sites133→132
2026-03-22
Study Status, Contacts/Locations v17
Study sites133 entries, revised
American Oncology Partners of Maryland, PA
2026-02-27
Study Status, Contacts/Locations v16
Study sites134→133
2026-02-09
Study Status, Contacts/Locations v15
Study sites135→134
Show 14 earlier versions
2026-01-19
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 135 sites
2026-01-12
Study Status, Contacts/Locations v13
Study sitesdetails revised at 2 of 135 sites
2025-12-16
Study Status, Contacts/Locations v12
Study sitesdetails revised at 4 of 135 sites
2025-12-08
Study Status, Contacts/Locations v11
Study sitesdetails revised at 4 of 135 sites
2025-11-19
Study Status, Contacts/Locations v10
Study sitesdetails revised at 2 of 135 sites
2025-10-10
Study Status, Contacts/Locations v9
Study sitesdetails revised at 135 of 135 sites
2025-09-24
Study Status, Contacts/Locations v8
Study sites136→135
2025-09-05
Study Status, Contacts/Locations v7
Study sitesdetails revised at 2 of 136 sites
2025-08-26
Study Status, Contacts/Locations v6
Study sitesdetails revised at 90 of 136 sites
2025-07-18
Study Status, Oversight, Contacts/Locations v5
Study sitesdetails revised at 136 of 136 sites
2025-06-18
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v4
Study sites138→136
Study arms3→4
Eligibility criteria+157 characters
Inclusion Criteria: Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria. Part 1: Have received prior CLL/SLL treatment Have received at least [...] reatment for CLL/SLL Have received a covalent BTK inhibitor Part 2: Have received no prior treatment for CLL/SLL Part 1 - Known 17p deletion status (positive or negative) Part 2 - Must have 17p deletion (positive) Have a requirement for therapy consistent with iwCLL 2018 cr [...] Criteria: Have received prior treatment with a BTK degrader andor a noncovalent BTK inhibitor Have a history of greater than [...] roval. Examples include: nonmelanoma [...]
2025-05-27
Study Status, Contacts/Locations v3
Study sites137→138
2025-04-17
Study Status, Contacts/Locations v2
Study sites137 entries, revised
Medical CollegeCity of WisconsinHope National Medical Center, Atlanta Cancer Center RoskildeFlinders SygehusMedical Centre GemeinschaftspraxisMV-Zentrum für HämatologieOnkologie und Onkologie MünsterHämatologie Semmelweis UniversityEgyetem SzpitalIN UniwersyteckiVIVO Pusan Nr 2 im. dr J. Biziela w Bydgoszczy Severance Hospital, YonseiNational University Health SystemHospital
2025-01-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11→confirmed 2025-01-03
Study sites0→137
2024-09-06
Original filing
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.
Trial Details
NCT Number NCT06588478
Lead Sponsor Loxo Oncology, Inc.
Collaborators: Eli Lilly and Company
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 249 participants
Start Date 2025-01-03
Primary Completion 2028-06 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-19