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), Ibrutinib (drug)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- Pirtobrutinib — drug: Administered orally. · Ibrutinib — drug: Administered orally.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study compares two drugs, pirtobrutinib (also called LOXO-305) and ibrutinib, in people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Chronic lymphocytic leukaemia is a slow-growing blood cancer. The study is run by the sponsor Loxo Oncology, Inc.
Who can take part
- You have a confirmed diagnosis of CLL or SLL and need treatment, based on standard 2018 guidelines (iwCLL 2018 criteria)
- For Part 1: your 17p deletion status (a genetic change) is known, whether present or not. For Part 2: you must have a 17p deletion, shown by a test called FISH
- You can carry out day-to-day activities at least half the time (performance status score 0-2 on a scale called ECOG)
- Your organs are working well enough, including blood counts and kidney function (for example, creatinine clearance of at least 30 millilitres per minute)
- For Part 2, you must not have had any previous treatment for CLL or SLL. For Part 1, you may or may not have had treatment before, but you must not have had a type of drug called a BTK inhibitor before
Who may not be able to
- Your CLL or SLL has changed into another cancer, such as a fast-growing lymphoma (Richter's transformation), prolymphocytic leukaemia, or Hodgkin's lymphoma, or is thought to have done
- The cancer has spread to the brain or spinal cord, or this is suspected
- You have a significant history of kidney, nerve, mental health, hormone, metabolic or immune system disease
- You have an active, uncontrolled blood cell destruction problem caused by the immune system (such as autoimmune haemolytic anaemia or ITP)
- You have serious heart disease, including a weak heart pump (ejection fraction under 40%) or ongoing atrial fibrillation or atrial flutter of any grade
- You have active hepatitis B or hepatitis C infection, based on screening blood tests
- You have active cytomegalovirus (CMV) infection, or an active uncontrolled bacterial, viral or fungal infection
- You have HIV infection
- You have a gut problem that affects how you absorb medicines by mouth, or ongoing inflammatory bowel disease
- You are taking an experimental drug or another cancer treatment (except hormone therapy) at the same time
- You need blood-thinning treatment with warfarin or a similar vitamin K antagonist
- You are taking more than 20 milligrams of prednisone a day, or an equivalent steroid, when the study drug starts
- You had a live vaccine within 28 days before joining the study
- You are on long-term treatment with a strong CYP3A inhibitor medicine (except posaconazole and voriconazole) that cannot be stopped before the study drug starts
- You have had a serious allergic reaction, including anaphylaxis, to pirtobrutinib or ibrutinib or anything in them
What taking part involves
- • Taking one of two study drugs by mouth: pirtobrutinib (LOXO-305) or ibrutinib
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
- 737
- Started
- 2022-07-22
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • Phase3 - 737 participants
- • The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Bristol - Bristol Haematology and Oncology Centre
- • Leicester - HOPE Centre
- • London - St Bartholomew's Hospital
- • Swansea - Singleton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
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:
- ✓ deletion of 17p as determined by FISH testing
What the study is looking for
- ✓Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- ✓Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH...
- ✓activity scale (ECOG) Performance Status 0-2
- ✓healthy organ
- ✓Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow...
Who cannot take part
- ✗Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or...
- ✗Known or suspected central nervous system (CNS) involvement
- ✗A significant history of kidney, neurologic, psychiatric, endocrine, metabolic or immunologic disease
- ✗Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic...
- ✗Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or...
See the full criteria
Where Is This Study? (4 UK sites)
Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
HOPE Centre
Leicester LE1 5WW, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, 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
