A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Launched by LOXO ONCOLOGY, INC. · Feb 15, 2022
Trial Information
Current as of October 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two medications, pirtobrutinib (also known as LOXO-305) and ibrutinib, to see which one is more effective and safer for people with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This study is open to adults aged 65 and older who have been diagnosed with CLL/SLL and need treatment. Participants will be monitored for up to six years and may include those who have already received treatment for their cancer or are starting treatment for the first time.
To qualify for the trial, participants need to have a confirmed diagnosis of CLL/SLL and meet certain health criteria, including having adequate blood counts and organ function. However, individuals with specific conditions, like certain types of lymphoma or active infections, may not be eligible. If you join the trial, you'll receive either of the two medications as part of the study, and the research team will keep a close eye on your health throughout the process. This trial is currently active but not enrolling new participants.
Gender
ALL
Eligibility criteria
- 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
About Loxo Oncology, Inc.
Loxo Oncology, Inc. is a biopharmaceutical company focused on the development of targeted therapies for patients with genetically defined cancers. With a commitment to precision medicine, Loxo Oncology leverages advanced genomic insights to identify and address the underlying causes of cancer, aiming to enhance treatment outcomes and improve patient quality of life. The company’s innovative pipeline includes novel therapies designed to inhibit specific oncogenic drivers, and it collaborates with leading research institutions and healthcare professionals to advance its clinical programs. Through a rigorous approach to research and development, Loxo Oncology strives to transform the treatment landscape for patients facing rare and challenging malignancies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nice, France
Providence, Rhode Island, United States
Fort Sam Houston, Texas, United States
Fort Myers, Florida, United States
Berkeley, California, United States
San Diego, California, United States
Barcelona, Spain
Hot Springs, Arkansas, United States
Adelaide, Australia
Badalona, Spain
Seoul, Korea, Republic Of
Berkeley, California, United States
Winnipeg, Manitoba, Canada
Detroit, Michigan, United States
Marietta, Georgia, United States
Swansea, United Kingdom
London, United Kingdom
Pamplona, Navarra, Spain
Barretos, Brazil
Sunderland, Tyne And Wear, United Kingdom
Hamilton, New Zealand
Detroit, Michigan, United States
Madrid, Spain
Santander, Spain
Leicester, Leicestershire, United Kingdom
Haifa, Israel
Sevilla, Spain
Tainan, Taiwan
Sevilla, Spain
Anaheim, California, United States
Kumamoto, Japan
Ulm, Baden Württemberg, Germany
Hamilton, New Zealand
Barrie, Ontario, Canada
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Bristol, United Kingdom
Rennes, France
Hradec Kralove, Czechia
Barcelona, Spain
Leuven, Belgium
Praha 10, Czechia
Milano, Italy
Barcelona, Spain
Billings, Montana, United States
Tours, France
Cottingham, East Yorkshire, United Kingdom
Ulm, Germany
Rouen Cedex, France
Izmir, Turkey
Tianjin, Tianjin, China
Brno, Czechia
Baton Rouge, Louisiana, United States
Milano, Italy
Dunedin, New Zealand
Istanbul, Turkey
Madrid, Spain
Whittier, California, United States
Guangzhou, Guangdong, China
Marbella, Malaga, Spain
Sao Paulo, Brazil
Milano, Italy
Changsha, Hunan, China
Majadahonda, Madrid, Spain
Shanghai, Shanghai, China
Haikou, Hainan, China
Majadahonda, Spain
Paris, France
St Albans, Victoria, Australia
Petah Tiqva, Israel
York, Pennsylvania, United States
Norwich, Connecticut, United States
Nanchang, Jiangxi, China
Saint Petersburg, Florida, United States
Barretos, São Paulo, Brazil
Milano, Italy
Roeselare, Belgium
Milano, Italy
Guangzhou, Guangdong, China
Madrid, Spain
Houston, Texas, United States
Tel Aviv, Israel
Nantes, France
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Hawthorne, New York, United States
Istanbul, Turkey
Hefei, Anhui, China
Billings, Montana, United States
Houston, Texas, United States
Lublin, Poland
São Paulo, Brazil
Bristol, Bristol, City Of, United Kingdom
Debrecen, Hungary
Szombathely, Hungary
Krakow, Poland
Ostrava Poruba, Czechia
L'hospitalet De Llobregat, Spain
Medford, Oregon, United States
La Roche Sur Yon, France
Cordoba, Argentina
Jerusalem, Israel
Verona, Italy
Hefei, Anhui, China
Parma, Italy
Louisville, Kentucky, United States
Tainan, Taiwan
Hangzhou, Zhejiang, China
Opole, Poland
Nanning, Guangxi, China
Nyiregyhaza, Hungary
Winston Salem, North Carolina, United States
Changsha, Hunan, China
Tel Hashomer, Israel
Dresden, Sachsen, Germany
Le Mans, France
Nanchang, Jiangxi, China
Greenville, South Carolina, United States
Mar Del Plata, Buenos Aires, Argentina
Praha 2, Czechia
Istanbul, Turkey
Norwich, Connecticut, United States
Dresden, Sachsen Anhalt, Germany
Wuhan, China
Milano, Lombardia, Italy
Katowice, Poland
Curitiba, Paraná, Brazil
Lakeland, Florida, United States
Bethesda, Maryland, United States
Badalona, Barcelona, Spain
Providence, Rhode Island, United States
Lakeland, Florida, United States
Wuhan City, Hubei, China
Shanghai, Shanghai, China
Linz, Austria
Papatoetoe, Auckland, New Zealand
Spokane, Washington, United States
Houston, Texas, United States
Chattanooga, Tennessee, United States
Alessandria, Italy
Haikou, China
West Perth, Australia
San Marcos, California, United States
Las Palmas De Gran Canaria, Spain
İzmir, Turkey
Rennes, Cedex 9, France
Ramat Gan, Israel
Isehara, Kanagawa, Japan
Curitiba, Brazil
Campinas, Sao Paulo, Brazil
Seocho Gu, Seoul, Korea, Republic Of
Meldola, Forlì Cesena, Italy
Badalona, Catalunya [Cataluña], Spain
Bologna, Italy
Madrid, Spain
Hefei, Anhui, China
Changsha, Hunan, China
Changsha, Hunan, China
Sevilla, Other, Spain
Taipei, Taiwan
Columbus, Ohio, United States
Candiolo, Torino, Italy
Hangzhou, China
Nottingham, Nottinghamshire, United Kingdom
Providence, Rhode Island, United States
Sint Niklaas, Oost Vlaanderen, Belgium
Wuhan, Hubei, China
Madrid, Spain
Salisbury, Maryland, United States
Hradec Kralove, Hradec Králové, Czechia
Tours, Tours Cedex 9, France
Jacksonville, Florida, United States
Pierre Benite, Cedex, France
Kerpener, Köln, Germany
Busan, Korea, Republic Of
Iwaszkiewicza 5, Legnica, Poland
Bydgoszcz, Poland
Wrocław, Poland
Barcelona, Other, Spain
Meldola, Italy
Greenville, South Carolina, United States
Barcelona, Cataluña, Spain
Shanghai, Shanghai, China
New Orleans, Louisiana, United States
New York, New York, United States
Charlotte, North Carolina, United States
Paris, France
Spokane, Washington, United States
Skorzewo, Poznan, Poland
Biała Podlaska, Poland
Changhua, Taiwan
Kingwood, Texas, United States
Petah Tikva, Hamerkaz, Israel
London, London, City Of, United Kingdom
Nedlands, Western Australia, Australia
Ciudad Autónoma De Buenos Aire, Buenos Aires, Argentina
Ribeirão Preto, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Richmond, Virginia, United States
Tianjin, Tianjin, China
Rouen Cedex, France
Opole, Poland
Santa Fe, Argentina
Petach Tikva, Israel
Nantes, Cedex 1, France
Limoges, France
Putz, Chiayi Hsien, Taiwan
Hangzhou, Other, China
Changsha, Other, China
Porto Alegre, Rio Grande Do Sul, Brazil
Debrecen, Hungary
Mamak, Ankara, Turkey
Ankara, Yenimahalle, Turkey
Brooksville, Florida, United States
Plzen Lochotin, Czechia
Nice, Nice Cedex 2, France
Yamagata, Japan
Majadahonda, Madrid, Comunidad De, Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Passo Fundo, Rio Grande Do Sul, Brazil
Otahuhu, New Zealand
Cerritos, California, United States
Melbourne, Other, Australia
Faith, Istanbul, Turkey
Campinas, São Paulo, Brazil
Ocean Pines, Maryland, United States
Abb, Ciudad Autónoma De Buenos Aire, Argentina
Seoul, Other, Korea, Republic Of
Santo André, São Paulo, Brazil
Cascavel, Brazil
Québec, Canada
Santiago, Región Metropolitana, Chile
Providencia, Santiago, Chile
Viña Del Mar, Valparaíso, Chile
Sao Jose Rio Preto, Other, Brazil
Yiwu, Zhejiang, China
Ciudad Autonoma Buenos Aires, Other, Argentina
Rancho Mirage, California, United States
Savannah, Georgia, United States
Memphis, Tennessee, United States
Round Rock, Texas, United States
Autonoma De Buenos Aires, Buenos Aires, Argentina
Cordoba, Argentina
Linz, Oberösterreich, Austria
Belo Horizonte, Minas Gera, Brazil
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Sao Paulo, Sp, Brazil
Botucatu, São Paulo, Brazil
São José Do Rio Preto, Brazil
São Paulo, Brazil
Barrie, Ontario, Canada
Temuco, Ix Región, Chile
Guang Zhou, P.R. China, China
Urumqi, Xinjiang, China
Magdeburg, Sachsen Anhalt, Germany
Dresden, Sachsen, Germany
Dortmund, Germany
Dresden, Germany
Tübingen, Germany
Reggio Emilia, Emilia Romagna, Italy
Newtown, Wellington, New Zealand
Gdansk, Pomorskie, Poland
Kraków, Poland
Lublin, Poland
Girona, Cataluna, Spain
Sarıyer, İstanbul, Turkey
Balçova, İzmir, Turkey
Bornova, Izmir, Turkey
Leicester, United Kingdom
Ribeirão Preto, São Paulo, Brazil
Nanchang, Other, China
Verona, Italy
Haikou, Other, China
Palo Alto, California, United States
Round Rock, Texas, United States
Spokane, Washington, United States
Spokane, Washington, United States
Mar Del Plata, Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Passo Fundo, Rio Grande Do Sul, Brazil
Botucatu, Sao Paulo, Brazil
Sao Jose Rio Preto, Sao Paulo, Brazil
Sao Paulo, Brazil
Urumqi, Xinjiang, China
Limoges, France
Tübingen, Baden Wuerttemberg, Germany
Ulm, Baden, Germany
Dortmund, Nordrhein Westfalen, Germany
Meldola, Forlì Cesena, Italy
Alessandria, Italy
Reggio Emilia, Italy
Dunedin, Otago, New Zealand
Wrocław, Poland
Istanbul, Turkey
Hull, East Riding Of Yorkshire, United Kingdom
Barcelona, Other, Spain
Linz, Austria
Curitiba, Paraná, Brazil
Yerushalayim, Israel
Candiolo, Torino, Italy
London, Middlesex, United Kingdom
Curitiba, Other, Brazil
Santo André, Brazil
Bornova, Izmir, Turkey
Vienna, Austria
São Paulo, Brazil
Torino, Otago, Italy
Mamak, Ankara, Turkey
Istanbul, Turkey
Istanbul, Turkey
Linz, Austria
Santiago, Chile
Tainan, Taiwan
Curitiba, Brazil
Kerpener, Germany
Abb, Argentina
Ribeirão Preto, Brazil
Temuco, Chile
Viña Del Mar, Chile
Balçova, Turkey
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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