Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion
Principal Investigator
by Susan O'Brien (uci)

Description

Summary

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)

Keywords

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

Eligibility

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

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Scripps Mercy Hospital accepting new patients
    San Diego California 92103 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Loxo Oncology, Inc.
ID
NCT04965493
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated