For Healthcare Professionals

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)


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  2. Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
  3. 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
  4. Adequate organ function
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  6. Estimated creatinine clearance ≥30 milliliters per minute (mL/min)


Exclusion Criteria:

  1. Known or suspected Richter's transformation at any time preceding enrollment
  2. Prior therapy with a non-covalent (reversible) BTK inhibitor
  3. Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  4. Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
  5. Prior therapy with venetoclax
  6. Central nervous system (CNS) involvement
  7. Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  8. Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  9. Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
  10. Active hepatitis B or hepatitis C
  11. Known active cytomegalovirus (CMV) infection
  12. Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
  13. Significant cardiovascular disease
  14. Vaccination with a live vaccine within 28 days prior to randomization

Patients with the following hypersensitivity:

  1. Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
  2. Prior significant hypersensitivity to rituximab
  3. Known allergy to allopurinol and inability to take uric acid lowering agent
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-855-LOXO-305Email iconEmail Study Center

Study’s details


Chronic Lymphocytic Leukemia,Small Lymphocytic Lymphoma

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Jan 31, 2027

Treatment type



Eli Lilly and Company identifier


Study number


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