Who is eligible for clinical trial NCT05254743?

Participants must meet protocol criteria for Chronic Lymphocytic Leukemia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05254743 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-14

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (NCT05254743)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Loxo Oncology, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (19 items).

Location: Pacific Cancer Medical Center, Inc — Anaheim, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (143 Sites)

Pacific Cancer Medical Center, Inc — Anaheim, California
TOI Clinical Research — Cerritos, California
Stanford School of Medicine-Cancer Clinical Trials Office — Palo Alto, California
California Cancer Associates for Research and Excellence — San Marcos, California
Florida Cancer Specialists — Fort Myers, Florida
Cancer Specialists of North Florida -St Augustine — Saint Augustine, Florida
Florida Cancer Specialists East — West Palm Beach, Florida
Hematology Oncology Clinic — Baton Rouge, Louisiana
Tulane Cancer Center Office of Clinical Research — New Orleans, Louisiana
American Oncology Partners of Maryland, PA — Bethesda, Maryland
St. Vincent Frontier Cancer Center — Billings, Montana
Cancer Care Associates Of York — York, Pennsylvania
Prisma Health Cancer Institute — Greenville, South Carolina
Sarah Cannon Research Institute SCRI — Nashville, Tennessee
Kelsey Research Foundation — Houston, Texas
Lumi Research — Kingwood, Texas
Virginia Cancer Institute — Richmond, Virginia
Medical Oncology Associates, PS — Spokane, Washington
MultiCare Health System Institute for Research and Innovation — Spokane, Washington
Alexander Fleming — Ciudad Autónoma de Buenos Aire,
Hospital Privado De Comunidad — Mar del Plata,
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares — Santa Fe,
One Clinical Research — Nedlands,
Western Health, Sunshine Hospital — St Albans,
The Perth Blood Institute — West Perth,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗