At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pirtobrutinib (drug)
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Pirtobrutinib — drug: Administered Orally.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how well a drug called pirtobrutinib works and how safe it is for people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Part 1 includes people whose cancer has come back or not responded to earlier treatment, while Part 2 includes people who have not had treatment before. The study is run by Loxo Oncology, Inc.
Who can take part
- You have a confirmed diagnosis of CLL or SLL, based on 2018 international guidelines (iwCLL 2018)
- For Part 1: you have had between 1 and 3 previous treatments for CLL or SLL, including a type of medicine called a covalent BTK inhibitor (a drug that blocks a protein called BTK)
- For Part 2: you have had no previous treatment for CLL or SLL
- For Part 1: your 17p deletion status is known (positive or negative). For Part 2: you must have a 17p deletion (a missing piece of chromosome 17)
- You need treatment now, based on the 2018 iwCLL guidelines
- You are able to swallow tablets, as the study medicine is taken by mouth
- You have an ECOG (Eastern Cooperative Oncology Group) performance score of 0 to 2, meaning you can mostly look after yourself
- Not stated — ask the trial team about age or other requirements
Who may not be able to
- You have had treatment with a BTK degrader or a non-covalent BTK inhibitor (other types of drugs that target the BTK protein)
- You have had serious bleeding (Grade 3 or worse) while taking a BTK inhibitor before
- You have or may have Richter's transformation (where CLL changes into a faster-growing type of cancer)
- You have or may have CLL or SLL in the brain or spinal cord (central nervous system)
- You had or have another cancer, other than CLL or SLL, within 3 years of joining the study — though some exceptions may be allowed, such as certain skin cancers, very early cervical cancer, prostate cancer under watchful waiting, or early breast cancer with no active disease for more than 3 years
What taking part involves
- • Taking pirtobrutinib as an oral medicine (swallowed as tablets)
- • Not stated — ask the trial team about how often you take it, the dose, or any other treatments involved
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 249
- Started
- 2025-01-03
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • Phase2 - 249 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Birmingham - Heartlands Hospital
- • Glasgow - The Beatson West of Scotland Cancer Centre
- • Harrow - Northwick Park Hospital
- • Leeds - St James's University Hospital
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ 17p deletion (positive)
What the study is looking for
- ✓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
Who cannot take part
- ✗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
- ✗Have known or suspected Richter's transformation
- ✗Have known or suspected history of central nervous system involvement by CLL/SLL
- ✗Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with...
See the full criteria
Where Is This Study? (9 UK sites)
Heartlands Hospital
Birmingham B9 5SS, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Northwick Park Hospital
Harrow HA1 3UJ, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Lincoln County Hospital
Lincoln LN2 5QY, United Kingdom
Clatterbridge Cancer Centre - Liverpool
Liverpool L7 8YA, United Kingdom
Hammersmith Hospital
London W12 0HS, United Kingdom
Maidstone Hospital
Maidstone ME16 9QQ, United Kingdom
Singleton Hospital
Swansea SA2 8QA, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT