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Purpose

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.

Conditions

Eligibility

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

Inclusion Criteria

  • 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 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 - 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

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 Part 1 		Participants will receive pirtobrutinib orally.
  • Drug: Pirtobrutinib
    Administered orally.
    Other names:
    • LOXO-305
    • LY3527727
Active Comparator
Ibrutinib Part 1 		Participants will receive ibrutinib orally.
  • Drug: Ibrutinib
    Administered orally.
Experimental
Pirtobrutinib Part 2 		Participants will receive pirtobrutinib orally.
  • Drug: Pirtobrutinib
    Administered orally.
    Other names:
    • LOXO-305
    • LY3527727

Recruiting Locations

Pacific Cancer Medical Center, Inc
Anaheim, California 92801
Contact:
714-999-1465

TOI Clinical Research
Cerritos, California 90703
Contact:
562-693-4477

Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California 94305
Contact:
650-498-6000

Florida Cancer Specialists
Fort Myers, Florida 33916-2233
Contact:
727-216-1143

Cancer Specialists of North Florida -St Augustine
Saint Augustine, Florida 32086
Contact:
904-538-4488

Florida Cancer Specialists East
West Palm Beach, Florida 33401
Contact:
561-366-4100

American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817
Contact:
301-571-0019

St. Vincent Frontier Cancer Center
Billings, Montana 59102
Contact:
406-238-6685

Sarah Cannon Research Institute SCRI
Nashville, Tennessee 37203
Contact:
423-622-6212

Lumi Research
Kingwood, Texas 77339

Virginia Cancer Institute
Richmond, Virginia 23230
Contact:
804-287-3000

Medical Oncology Associates, PS
Spokane, Washington 99208
Contact:
509-462-2273

More Details

Status
Recruiting
Sponsor
Loxo Oncology, Inc.

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@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.