A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Running, not enrolling · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Key facts

Study ID

NCT04965493

Run by

Loxo Oncology, Inc.

People needed

600

Starts

2021-09-20

Expected to finish

2027-10-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
• Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
• Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
• Adequate organ function
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

You may not qualify if…

• Known or suspected Richter's transformation at any time preceding enrollment
• Prior therapy with a non-covalent (reversible) BTK inhibitor
• Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
• Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
• Prior therapy with venetoclax
• Central nervous system (CNS) involvement
• Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
• Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
• Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
• Active hepatitis B or hepatitis C
• Known active cytomegalovirus (CMV) infection
• Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
• Significant cardiovascular disease
• Vaccination with a live vaccine within 28 days prior to randomization
• Patients with the following hypersensitivity:
• Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
• Prior significant hypersensitivity to rituximab
• Known allergy to allopurinol and inability to take uric acid lowering agent

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• University of California Irvine Medical Center — Orange, California, United States
• Scripps Mercy Hospital — San Diego, California, United States
• Providence Medical Foundation — Santa Rosa, California, United States
• Stamford Hospital — Stamford, Connecticut, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Cancer Specialists of North Florida -St Augustine — Saint Augustine, Florida, United States
• Florida Cancer Specialists East — West Palm Beach, Florida, United States
• Mission Cancer and Blood — Des Moines, Iowa, United States
• Pikeville Medical Center, Inc. — Pikeville, Kentucky, United States
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Research Medical Center — Kansas City, Missouri, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Mount Sinai Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Novant Cancer Institute Charlotte — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Regional Medical Oncology Center — Wilson, North Carolina, United States
• Ironwood Physicians, Ironwood Cancer and Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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