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Search / Trial NCT05254743

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 02, 2025

Recruiting

Keywords

Bt Ki Hematologic Disease Lymphoma, Non Hodgkin's Lymphoma, B Cell

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.

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

0 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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