Status:
RECRUITING
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Lead Sponsor:
Loxo Oncology, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
662 Patients enrolled
Trial Details
Trial ID
NCT05254743
Start Date
July 22 2022
End Date
January 1 2028
Last Update
December 24 2025
Active Locations (144)
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1
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
2
TOI Clinical Research
Cerritos, California, United States, 90703
3
Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California, United States, 94305
4
California Cancer Associates for Research and Excellence
San Marcos, California, United States, 92069