Back to search results

Study of Pirtobrutinib vs. Ibrutinib for CLL/SLL

This study is testing two oral medications, pirtobrutinib (LOXO-305) and ibrutinib, for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Part 1 compares pirtobrutinib to ibrutinib in people who may or may not have had prior treatment. Part 2 looks at pirtobrutinib alone in people who haven't had treatment and have a specific genetic change called a 17p deletion. The study aims to see how many participants achieve a complete or partial response to the treatments. You may be able to join if you are 18 or older, have a confirmed diagnosis of CLL/SLL requiring treatment, and meet certain health requirements, including specific blood counts. The study is planning to enroll 737 participants, but its current status is unclear.

Study design
This is an interventional study comparing two drugs, pirtobrutinib and ibrutinib, in participants with CLL/SLL. It is planned to enroll 737 participants.
What's involved
Participation could last up to six years for Part 1 of the study, or up to two years for Part 2.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be measured for approximately 3 years and 5 months for Part 1, and approximately 2 years and 3 months for Part 2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05254743

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Loxo Oncology, Inc.
~737 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PirtobrutinibIbrutinib

At a glance

Recruiting sites
93 of 143 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1
Measured over Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months)
+1 more outcome measured

Conditions

Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic
Leukemia, B-cell
Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma17p

Where it's being run

143 sites across 33 states
China18
Brazil14
Spain13
France10
Poland8
Turkey (Türkiye)7
Czechia6
Italy6

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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).
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

What this trial measures

  • Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months)

    ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

  • Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest (Approximately 2 years and 3 months)

    ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria