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

Purpose

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.

Conditions

  • Chronic Lymphocytic Leukemia
  • Leukemia, Lymphocytic
  • Leukemia, B-cell
  • Small Lymphocytic Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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) 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 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 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 - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pirtobrutinib 		Administered orally.
  • Drug: Pirtobrutinib
    Administered orally.
    Other names:
    • LOXO-305
    • LY3527727
Active Comparator
Ibrutinib 		Administered orally.
  • Drug: Ibrutinib
    Administered orally.

Recruiting Locations

Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana 70112
Contact:
504-988-6234

More Details

Status
Recruiting
Sponsor
Loxo Oncology, Inc.

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com