Titre A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Protocole ID BRUIN-CLL-314
ClinicalTrials.gov ID NCT05254743
Type(s) de cancer Leucémie lymphoïde chronique (LLC)
Phase Phase III
Type étude Clinique
Médicament Pirtobrutinib versus Ibrutinib
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dr Robert Delage
Coordonnateur(trice) Philippe Nadeau
 418-649-0252 poste 63115
Statut Fermé
Date d'activation 30-01-2023
Critètes d'éligibilité
  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to (≥)50 x 10?/liter (L), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10?/L
  • Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
Critètes d'exclusion
  • Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
  • Known or suspected central nervous system (CNS) involvement
  • A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease
  • Active hepatitis B or hepatitis C
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, or fungal infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
  • Ongoing inflammatory bowel disease
  • Prior exposure to BTK inhibitor (covalent or noncovalent)
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
  • Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib