A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Launched by LOXO ONCOLOGY, INC. · Sep 6, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called Pirtobrutinib to see how well it works and how safe it is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not responded to previous treatments. Specifically, the trial is aimed at patients who have already undergone 1 to 3 treatments and have taken a specific type of drug known as a covalent BTK inhibitor. The study is expected to last about three years, and it is currently looking for participants aged 65 to 74 years old, regardless of gender.
To be eligible for this trial, participants must have a confirmed diagnosis of CLL or SLL and have received prior treatment for their condition. They should be capable of swallowing pills and have a performance status that indicates they can carry out daily activities. However, individuals who have had certain serious complications from previous treatments or other specific health issues may not be able to participate. Those who join the trial can expect to take the medication and attend regular check-ups to monitor their health and response to the treatment. This trial could provide valuable information that may help improve future treatments for CLL and SLL.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
- • Part 1: Have received prior CLL/SLL treatment
- • Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
- • Have received a covalent BTK inhibitor
- • Part 2: Have received no prior treatment for CLL/SLL
- • Part 1 - Known 17p deletion status (positive or negative)
- • Part 2 - Must have 17p deletion (positive)
- • Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
- • Capable of swallowing oral study medication.
- • Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.
- Exclusion Criteria:
- • Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
- • Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
- • Have known or suspected Richter's transformation
- • Have known or suspected history of central nervous system involvement by CLL/SLL
- * Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
- • nonmelanoma skin cancer or lentigo malignant melanoma
- • cervical carcinoma in situ
- • localized prostate cancer undergoing active surveillance, and
- • localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy
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
Milwaukee, Wisconsin, United States
Boston, Massachusetts, United States
Madrid, , Spain
Duarte, California, United States
Hobart, Tasmania, Australia
Box Hill, Victoria, Australia
Woolloongabba, Queensland, Australia
Greenville, North Carolina, United States
Coffs Harbour, New South Wales, Australia
Swansea, , United Kingdom
Bankstown, New South Wales, Australia
Barcelona, , Spain
Santander, Cantabria, Spain
Madrid, , Spain
Budapest, , Hungary
London, , United Kingdom
Glasgow, , United Kingdom
Waratah, New South Wales, Australia
Adelaide, South Australia, Australia
Sevilla, , Spain
Sevilla, , Spain
Barrie, Ontario, Canada
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bratislava, , Slovakia
Martin, , Slovakia
Barcelona, , Spain
Birmingham, , United Kingdom
Henderson, Nevada, United States
Hradec Kralove, , Czechia
Westbury, New York, United States
Marbella, Málaga, Spain
Budapest, , Hungary
Marbella, , Spain
Leeds, , United Kingdom
Aurora, Colorado, United States
Harrow, , United Kingdom
Leuven, Vlaams Brabant, Belgium
Maidstone, Kent, United Kingdom
Palo Alto, California, United States
Majadahonda, , Spain
Chandler, Arizona, United States
York, Pennsylvania, United States
Anderlecht, , Belgium
Madrid, , Spain
Gulfport, Mississippi, United States
Madrid, , Spain
Prague, , Czechia
Busan, , Korea, Republic Of
Oviedo, Asturias, Spain
Szeged, Csongrád, Hungary
Gent, Oost Vlaanderen, Belgium
Pécs, Baranya, Hungary
London, London, City Of, United Kingdom
Frankfurt, Hessen, Germany
Hannover, Niedersachsen, Germany
Madrid, , Spain
Praha 2, , Czechia
Katowice, , Poland
Seoul, , Korea, Republic Of
Bethesda, Maryland, United States
Athens, , Greece
Roma, , Italy
Bucuresti, , Romania
Szeged, , Hungary
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Firenze, Toscana, Italy
Sevilla, Andalucía, Spain
Bydgoszcz, Kujawsko Pomorskie, Poland
Madrid, , Spain
Aschaffenburg, Bayern, Germany
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Madrid, Madrid, Comunidad De, Spain
Salamanca, , Spain
Aarhus, Midtjylland, Denmark
Chaidari, , Greece
Banska Bystrica, , Slovakia
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Edgewood, Kentucky, United States
Odense, Syddanmark, Denmark
Thessaloniki, Thessaloníki, Greece
Chaidari, Attikí, Greece
Novara, , Italy
Ottignies, Brabant Wallon, Belgium
Katowice, śląskie, Poland
Brno, Brno Město, Czechia
Hradec Kralove, Hradec Králové, Czechia
Des Moines, Iowa, United States
Budapest, , Hungary
West Perth, Western Australia, Australia
Roeselare, West Vlaanderen, Belgium
Chicoutimi, Quebec, Canada
Barcelona, Barcelona [Barcelona], Spain
Athens, Attikí, Greece
Hwasun Gun, Jeonranamdo, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
L'hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Ankara, , Turkey
Wrocław, , Poland
Miami, Florida, United States
Barcelona, Catalunya [Cataluña], Spain
Koblenz, Rheinland Pfalz, Germany
Bari, Puglia, Italy
Brugge, West Vlaanderen, Belgium
Anderlecht, Bruxelles Capitale, Région De, Belgium
La Louvière, Hainaut, Belgium
Verviers, , Belgium
Samsun, , Turkey
Bratislava, Bratislavský Kraj, Slovakia
Germantown, Tennessee, United States
Harrow, London, City Of, United Kingdom
Perugia, Umbria, Italy
Badalona, Barcelona [Barcelona], Spain
Roma, Lazio, Italy
Craiova, Dolj, Romania
Majadahonda, Madrid, Comunidad De, Spain
Ovidiu, , Romania
Madrid, Madrid, Comunidad De, Spain
Nice, Alpes Maritimes, France
Kraków, , Poland
Verviers, Liège, Belgium
Ovidiu, Constanța, Romania
Nashville, Tennessee, United States
Seoul, , Korea, Republic Of
Sint Niklaas, Oost Vlaanderen, Belgium
Padova, Veneto, Italy
Liverpool, , United Kingdom
Izmir, , Turkey
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Roskilde, Sjælland, Denmark
Cluj, , Romania
Traralgon, Victoria, Australia
Kraków, Małopolskie, Poland
Antalya, , Turkey
Madrid, Madrid, Comunidad De, Spain
Cona, Emilia Romagna, Italy
Austin, Texas, United States
Prague, , Czechia
Mersin, , Turkey
București, , Romania
Iași, , Romania
Bucuresti, București, Romania
Izmit, Kocaeli, Turkey
Tours, Indre Et Loire, France
Cologne, Nordrhein Westfalen, Germany
Kurralta Park, South Australia, Australia
Münster, Nordrhein Westfalen, Germany
Skórzewo, Wielkopolskie, Poland
Irvine, California, United States
Palo Alto, California, United States
Eugene, Oregon, United States
Hampton, Virginia, United States
Vancouver, Washington, United States
Saskatoon, Saskatchewan, Canada
Mulhouse, Alsace, France
Caen, Calvados, France
Toulouse, Haute Garonne, France
Le Mans, Sarthe, France
Argenteuil, Val D'oise, France
Goettingen, Niedersachsen, Germany
αthens, Attikí, Greece
Milan, Lombardia, Italy
Palermo, Sicilia, Italy
Wrocław, Dolnośląskie, Poland
Banska Bystrica, Banskobystrický Kraj, Slovakia
Kosice, Košický Kraj, Slovakia
Martin, žilinský Kraj, Slovakia
Madrid, Madrid, Comunidad De, Spain
Adapazarı, Sakarya, Turkey
Ankara, , Turkey
Istanbul, , Turkey
Lincoln, , United Kingdom
Newnan, Georgia, United States
Waukee, Iowa, United States
The Woodlands, Texas, United States
Bydgoszcz, Kujawsko Pomorskie, Poland
Thessaloniki, , Greece
Badalona, , Spain
Brno, , Czechia
L'hospitalet Del Llobregat, , Spain
αthens, , Greece
Kosice, , Slovakia
Lincoln, Lincolnshire, United Kingdom
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