Non Hodgkin Lymphoma Clinical Trial
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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.
Eligibility 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
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There are 76 Locations for this study
Hot Springs Arkansas, 71913, United States More Info
Principal Investigator
Anaheim California, 92801, United States More Info
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Cerritos California, 90703, United States More Info
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San Marcos California, 92069, United States More Info
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Brooksville Florida, 34613, United States More Info
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Fort Myers Florida, 33901, United States More Info
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Jacksonville Florida, 32256, United States More Info
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Saint Petersburg Florida, 33705, United States More Info
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West Palm Beach Florida, 33401, United States More Info
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Baton Rouge Louisiana, 70809, United States More Info
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New Orleans Louisiana, 70112, United States More Info
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Bethesda Maryland, 20817, United States More Info
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Ocean Pines Maryland, 21811, United States More Info
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Salisbury Maryland, 21801, United States More Info
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Billings Montana, 59102, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Winston-Salem North Carolina, 27103, United States More Info
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Medford Oregon, 97504, United States More Info
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York Pennsylvania, 17403, United States More Info
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Chattanooga Tennessee, 37404, United States More Info
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Houston Texas, 77025, United States More Info
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Richmond Virginia, 23228, United States More Info
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ABB Ciudad Autónoma De Buenos Aire, 1199, Argentina More Info
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Santa Fe , 3000, Argentina More Info
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Nedlands Western Australia, 6009, Australia More Info
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Sint-Niklaas Oost-Vlaanderen, 9100, Belgium More Info
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Leuven , 3000, Belgium More Info
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Ribeirão Preto São Paulo, 14051, Brazil More Info
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Santo André São Paulo, 09060, Brazil More Info
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Cascavel , 85806, Brazil More Info
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Santiago Región Metropolitana, 83200, Chile More Info
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Providencia Santiago, 75006, Chile More Info
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Viña del Mar Valparaíso, 25200, Chile More Info
Principal Investigator
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