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RecruitingPhase 3

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

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 years, 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participation could last up to six years for Part 1."
  • "Participation could last up to 2 years for Part 2."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two types of blood cancer. Part 1 compares how well pirtobrutinib and ibrutinib work and how safe they are in people with or without past treatment. Part 2 tests pirtobrutinib alone in people who have not had treatment and have a missing piece of a chromosome called a 17p deletion.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have confirmed CLL or SLL that needs treatment under study guidelines.
  • For Part 1, testing must show whether you have a 17p deletion.
  • For Part 2, a lab test called FISH must show a 17p deletion, and you must not have had CLL/SLL treatment.
  • You must be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Your organs must work well enough, and your blood cell counts must meet study limits. Lower counts may be allowed if cancer in the bone marrow affects blood cell production.
  • Your kidney filtering rate must be at least 30 milliliters per minute.

Who can't join

  • Your cancer has changed, or may have changed, into certain other blood cancers, or it is known or suspected to involve the brain or spinal cord.
  • You have a serious history of kidney, nerve, mental health, hormone, metabolism, or immune system disease; uncontrolled low blood counts caused by your immune system; or serious heart disease, including ongoing atrial fibrillation or flutter (irregular heart rhythms).
  • You have active hepatitis B, hepatitis C, or cytomegalovirus (CMV); HIV; or an uncontrolled bacterial, viral, or fungal infection affecting the body.
  • You have ongoing inflammatory bowel disease or a condition that may keep your gut from absorbing the study pills properly.
  • For Part 1, you have taken a BTK inhibitor, a type of cancer drug. For Part 2, you have had any CLL/SLL treatment.
  • You are taking another study drug or cancer treatment other than hormone therapy, need warfarin or a similar blood thinner, or take more than 20 mg of prednisone daily or an equal dose of another steroid when study treatment starts.
  • You received a live vaccine within 28 days before random assignment, or you regularly take certain medicines called strong CYP3A inhibitors that cannot be stopped in time. Posaconazole and voriconazole are exceptions.
  • You have a known allergy to any ingredient in pirtobrutinib or ibrutinib.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (19)

CA

FL

LA

MD

MT

PA

SC

TN

TX

VA

WA