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Recruiting Phase 3

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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About this study

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Condition
Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma
Tested
Pirtobrutinib, Ibrutinib
Sponsor
Loxo Oncology, Inc.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Study condition: Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma
  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
  • Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
  • Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
  • Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion 19

  • 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 including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
  • Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
  • 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
  • Previous treatment for CLL/SLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
  • Part 2: participants must be treatment naïve
  • 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

Where

143 sites, 93 recruiting

Alexander Fleming

Ciudad Autónoma de Buenos Aire, Argentina

Recruiting

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

Santa Fe, Argentina

Recruiting

The Perth Blood Institute

West Perth, Australia

Recruiting

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

Recruiting

VITAZ

Sint-Niklaas, Belgium

Recruiting

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, Brazil

Recruiting

and 137 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.