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)

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• Ironwood Physicians, Ironwood Cancer and Research Centers
  Chandler, Arizona, United States
• 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

+126 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) — Eli Lilly and Company

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.