for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
completion around
Principal Investigator
by Catherine Coombs



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.

Official Title

A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)


Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, BTKi, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell, Lymphoma, Leukemia, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Rituximab, Venetoclax, Pirtobrutinib


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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


  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Sharp Memorial Hospital accepting new patients
    San Diego California 92123 United States

Lead Scientist at UC Irvine

  • Catherine Coombs
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 27 research publications


accepting new patients
Start Date
Completion Date
Loxo Oncology, Inc.
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) (BRUIN CLL-322)
Phase 3 research study
Study Type
Expecting 600 study participants
Last Updated