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Looking for participantsPhase3

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Sponsor: Loxo Oncology, Inc.

NCT ID: NCT05254743

View on ClinicalTrials.gov ↗

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.

Chronic Lymphocytic LeukemiaLeukemia, LymphocyticLeukemia, B-cellSmall Lymphocytic Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

CD4

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
Inclusion Criteria: * 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 testing * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Adequate organ function * Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, * Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis * Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min) Exclusion Criteria: * Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment * Known or suspected central nervous system (CNS) involvement * A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease * Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\]) * Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter * Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests * Active cytomegalovirus (CMV) infection * Active uncontrolled systemic bacterial, viral, or fungal infection * Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count * Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments * Ongoing inflammatory bowel disease * Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent). Part 2: participants must be treatment naïve * Concurrent use of investigational agent or anticancer therapy except hormonal therapy * Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist * Use of \> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug * Vaccination with a live vaccine within 28 days prior to randomization * Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment * Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Where Is This Study? (4 UK sites)

Bristol Haematology and Oncology Centre

Bristol BS2 8ED, United Kingdom

Recruiting
Site contact (verified)
Sanne LugthartPrincipal Investigator

HOPE Centre

Leicester LE1 5WW, United Kingdom

ACTIVE_NOT_RECRUITING

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

ACTIVE_NOT_RECRUITING

Singleton Hospital

Swansea SA2 8QA, United Kingdom

Recruiting
Site contact (verified)
Unmesh MohitePrincipal Investigator

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08