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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.