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A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT06588478 · Eli Lilly and Company
In plain English
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Official title
A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor
About this study
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.
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
Study design
Enrollment target: 249 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-03
Estimated completion: 2028-12
Last updated: 2026-03-24
Interventions
Drug: Pirtobrutinib
Primary outcomes
- • Overall Response Rate (Baseline up to 3 years)
Sponsor
Loxo Oncology, Inc. · industry
With: Eli Lilly and Company
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (133)
Ironwood Cancer & Research CentersRecruiting
Chandler, Arizona, United States
City of Hope National Medical CenterRecruiting
Duarte, California, United States
City of Hope National Medical CenterRecruiting
Irvine, California, United States
Palo Alto Medical Foundation Research Institute (PAMFRI)Recruiting
Palo Alto, California, United States
Stanford Cancer CenterRecruiting
Palo Alto, California, United States
Rocky Mountain Cancer CenterRecruiting
Aurora, Colorado, United States
University of Miami Hospital and Clinics, Sylvester Cancer CenterRecruiting
Miami, Florida, United States
City of Hope National Medical Center, Atlanta Cancer CenterRecruiting
Newnan, Georgia, United States
Mission Cancer + BloodRecruiting
Waukee, Iowa, United States
Saint Elizabeth Medical Center EdgewoodRecruiting
Edgewood, Kentucky, United States
American Oncology Partners, PARecruiting
Bethesda, Maryland, United States
Boston Medical CenterRecruiting
Boston, Massachusetts, United States
Gulfport Memorial HospitalRecruiting
Gulfport, Mississippi, United States
Comprehensive Cancer Centers of NevadaRecruiting
Henderson, Nevada, United States
East Carolina UniversityRecruiting
Greenville, North Carolina, United States
Williamette Valley Cancer Institute & Research CenterRecruiting
Eugene, Oregon, United States
Cancer Care Associates Of YorkRecruiting
York, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer CenterRecruiting
Germantown, Tennessee, United States
USO-Texas Oncology-Central/South TexasRecruiting
Austin, Texas, United States
Sarah Cannon Research Institute/SCRIRecruiting
The Woodlands, Texas, United States
USO-Virginia Oncology AssociatesRecruiting
Hampton, Virginia, United States
Flinders Medical CentreRecruiting
Adelaide, Australia
Bankstown-Lidcombe HospitalRecruiting
Bankstown, Australia
Box Hill HospitalRecruiting
Box Hill, Australia
Coffs Harbour Health CampusRecruiting
Coffs Harbour, Australia
Royal Hobart HospitalRecruiting
Hobart, Australia
ICON Cancer Centre - Kurralta ParkRecruiting
Kurralta Park, Australia
Latrobe Regional HealthRecruiting
Traralgon, Australia
Calvary Mater NewcastleRecruiting
Waratah, Australia
The Perth Blood Institute - West PerthRecruiting
West Perth, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Australia
Institut Jules BordetRecruiting
Anderlecht, Belgium
AZ Sint-Jan Brugge-Oostende AVRecruiting
Bruges, Belgium
UZ GentRecruiting
Ghent, Belgium
Groupe JolimontRecruiting
La Louvière, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Clinique Saint PierreRecruiting
Ottignies, Belgium
AZ Delta vzwRecruiting
Roeselare, Belgium
AZ NikolaasRecruiting
Sint-Niklaas, Belgium
CHR Verviers - La TourelleRecruiting
Verviers, Belgium
Royal Victoria Regional Health CentreRecruiting
Barrie, Canada
Saskatoon Cancer CentreRecruiting
Saskatoon, Canada
Fakultní nemocnice Brno BohuniceRecruiting
Brno, Czechia
Fakultni nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Fakultni nemocnice Kralovske VinohradyRecruiting
Prague, Czechia
Vseobecna fakultni nemocnice v PrazeRecruiting
Prague, Czechia
Aarhus Universitetshospital, SkejbyRecruiting
Aarhus, Denmark
Odense UniversitetshospitalRecruiting
Odense, Denmark
Centre Hospitalier d'Argenteuil Victor DupouyRecruiting
Argenteuil, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de NacreRecruiting
Caen, France
Centre Hospitalier du MansRecruiting
Le Mans, France
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile MullerRecruiting
Mulhouse, France
Centre Antoine-LacassagneRecruiting
Nice, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital BretonneauRecruiting
Tours, France
MV-Zentrum für Onkologie und HämatologieRecruiting
Cologne, Germany
Centrum für Hämatologie und Onkologie BethanienRecruiting
Frankfurt, Germany
OSP GöttingenRecruiting
Göttingen, Germany
Onkologisches Ambulanzzentrum HannoverRecruiting
Hanover, Germany
Klinikum Aschaffenburg-AlzenauRecruiting
Hösbach, Germany
InVO Institut für Versorgungsforschung in der OnkologieRecruiting
Koblenz, Germany
Evangelismos General Hospital of AthensRecruiting
Athens, Greece
Attikon General University HospitalRecruiting
Chaïdári, Greece
G. Papanikolaou General HospitalRecruiting
Thessaloniki, Greece
General Hospital of Athens "Laiko"Recruiting
Αthens, Greece
Semmelweis EgyetemRecruiting
Budapest, Hungary
Dél-Pesti CentrumkórházRecruiting
Budapest, Hungary
Pécsi Tudományegyetem Klinikai KözpontRecruiting
Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai KözpontRecruiting
Szeged, Hungary
A.O.U.C. Policlinico di BariRecruiting
Bari, Italy
Azienda Ospedaliero Universitaria S.AnnaRecruiting
Cona, Italy
Azienda Ospedaliera Universitaria CareggiRecruiting
Florence, Italy
ASST Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Azienda Ospedaliero Universitaria Maggiore della CaritàRecruiting
Novara, Italy
Azienda Ospedale - Università PadovaRecruiting
Padova, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLORecruiting
Palermo, Italy
AO Santa Maria della MisericordiaRecruiting
Perugia, Italy
AOU Policlinico Umberto IRecruiting
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
Roma, Italy
IN VIVORecruiting
Bydgoszcz, Poland
Pratia Onkologia KatowiceRecruiting
Katowice, Poland
Pratia MCM KrakowRecruiting
Krakow, Poland
AIDPORT Sp. z o.o.Recruiting
Skórzewo, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuRecruiting
Wroclaw, Poland
Fundeni Clinical InstituteRecruiting
Bucharest, Romania
Spitalul Clinic ColțeaRecruiting
Bucharest, Romania
Institutul Oncologic ClujRecruiting
Cluj-Napoca, Romania
Spitalul Clinic Municipal Filantropia CraiovaRecruiting
Craiova, Romania
Institutul Regional de OncologieRecruiting
Iași, Romania
Ovidius Clinical Hospital OCHRecruiting
Ovidiu, Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska BystricaRecruiting
Banská Bystrica, Slovakia
Narodny onkologicky ustavRecruiting
Bratislava, Slovakia
Univerzitna Nemocnica L. Pasteura KosiceRecruiting
Košice, Slovakia
Univerzitna nemocnica MartinRecruiting
Martin, Slovakia
Pusan National University HospitalRecruiting
Busan, South Korea
Chonnam National University Hwasun HospitalRecruiting
Hwasun-gun, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's HospitalRecruiting
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's HospitalRecruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - BadalonaRecruiting
Badalona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Clínic de BarcelonaRecruiting
Barcelona, Spain
Institut Català d'Oncologia - L'HospitaletRecruiting
L'Hospitalet Del Llobregat, Spain
Clinica Universidad de NavarraRecruiting
Madrid, Spain
Hospital Universitario Infanta LeonorRecruiting
Madrid, Spain
MD Anderson Cancer CenterRecruiting
Madrid, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario Quironsalud MadridRecruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Spain
Hospital Costa del SolRecruiting
Marbella, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaRecruiting
Salamanca, Spain
Hospital Universitario Marqués de ValdecillaRecruiting
Santander, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain
Sakarya University School of MedicineRecruiting
Adapazarı, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma HastanesiRecruiting
Ankara, Turkey (Türkiye)
Ankara University Health Practice and Research HospitalsRecruiting
Ankara, Turkey (Türkiye)
Memorial Antalya HospitalRecruiting
Antalya, Turkey (Türkiye)
Yeditepe Üniversitesi Koşuyolu HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Ege Universitesi HastanesiRecruiting
Izmir, Turkey (Türkiye)
Kocaeli ÜniversitesiRecruiting
İzmit, Turkey (Türkiye)
VM Medical Park Mersin HastanesiRecruiting
Mersin, Turkey (Türkiye)
Ondokuz Mayıs UniversitesiRecruiting
Samsun, Turkey (Türkiye)
Heartlands HospitalRecruiting
Birmingham, United Kingdom
The Beatson West of Scotland Cancer CentreRecruiting
Glasgow, United Kingdom
Northwick Park HospitalRecruiting
Harrow, United Kingdom
St James's University HospitalRecruiting
Leeds, United Kingdom
Lincoln County HospitalRecruiting
Lincoln, United Kingdom
Clatterbridge Cancer Centre - LiverpoolRecruiting
Liverpool, United Kingdom
Hammersmith HospitalRecruiting
London, United Kingdom
Maidstone HospitalRecruiting
Maidstone, United Kingdom
Singleton HospitalRecruiting
Swansea, United Kingdom