Tests 3 doses of pirtobrutinib in chronic lymphocytic leukemia or small lymphocytic lymphoma
Tests pirtobrutinib in adults whose chronic lymphocytic leukemia or lymphoma came back.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Key facts
- Where
- Bari, Ferrara, Florence, Milan, Novara, Padova, Palermo, Perugia, and Rome, ItalySee the 10 sites
- Phase
- Phase 2
Where in Italy
- Policlinico di Bari, AOU Consorziale Policlinico di BariBari, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant'AnnaFerrara, ItalyTaking people
- Careggi University HospitalFlorence, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloPalermo, ItalyTaking people
- Hospital Santa Maria Della MisericordiaPerugia, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Loxo Oncology, Inc.
- Trial code
- NCT06588478EU 2024-515689-15-01
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
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.
Inclusion: Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria; Part 1: Have received prior CLL/SLL treatment; Have received at least 1, but not more than 3 lines of prior treatment 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 criteria for initiation of therapy; Capable of swallowing oral study medication; Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
Exclusion: Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor; Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor; Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:; nonmelanoma skin cancer or lentigo malignant melanoma; cervical carcinoma in situ; localized prostate cancer undergoing active surveillance, and; localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy; Have known or suspected history of central nervous system involvement by CLL/SLL; Have known or suspected Richter's transformation.