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)

Sponsor: Loxo Oncology, Inc.

Sponsor score: 40

ClinicalTrials ID:NCT04965493

This clinical trial evaluates the efficacy and safety of adding pirtobrutinib to venetoclax and rituximab in previously treated CLL/SLL patients. Eligible participants must have adequate organ function, ECOG status 0-2, and meet specific blood count criteria. Interventions include oral pirtobrutinib and venetoclax, and IV rituximab. Participation may last up to five years.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
Mitchell Cancer Institute -University of South Alabama36604MobileAlabama
Mayo Clinic Arizona85054PhoenixArizona
Arizona Oncology Associates, P.C. - HOPE85711TucsonArizona
University of Arizona Cancer Center85724TucsonArizona
Marin Specialty Care, Inc94904GreenbraeCalifornia
University of California Irvine Medical Center92868OrangeCalifornia
University of California Irvine Medical Center92868OrangeCalifornia
Scripps Mercy Hospital92103San DiegoCalifornia
Sharp Memorial Hospital92123San DiegoCalifornia
Providence Medical Foundation95403Santa RosaCalifornia

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