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

• Status: Not yet recruiting
• Trial end date: 2029-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose 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. Participation could last up to six years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loxo Oncology, Inc.

Criteria

Inclusion Criteria:

• 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 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L

• Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

• 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