A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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
3 other identifiers
interventional
249
18 countries
133
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2025
Typical duration for phase_2
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
January 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 24, 2026
March 1, 2026
3.4 years
September 6, 2024
March 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.
Baseline up to 3 years
Secondary Outcomes (1)
Duration of Response
Baseline up to 3 years
Study Arms (4)
Pirtobrutinib Standard Dose (Dose 1)-Part 1
ACTIVE COMPARATORPirtobrutinib administered orally.
Pirtobrutinib Dose 2-Part 1
EXPERIMENTALPirtobrutinib administered orally.
Pirtobrutinib Dose 3-Part 1
EXPERIMENTALPirtobrutinib administered orally.
Pirtobrutinib Standard Dose-Part 2
EXPERIMENTALPirtobrutinib administered orally.
Interventions
Administered Orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loxo Oncology, Inc.lead
- Eli Lilly and Companycollaborator
Study Sites (133)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
City of Hope National Medical Center
Irvine, California, 92618, United States
Palo Alto Medical Foundation Research Institute (PAMFRI)
Palo Alto, California, 94304, United States
Stanford Cancer Center
Palo Alto, California, 94304, United States
Rocky Mountain Cancer Center
Aurora, Colorado, 80012, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136, United States
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265, United States
Mission Cancer + Blood
Waukee, Iowa, 50263, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017, United States
American Oncology Partners, PA
Bethesda, Maryland, 20817, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, 39501, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Williamette Valley Cancer Institute & Research Center
Eugene, Oregon, 97401, United States
Cancer Care Associates Of York
York, Pennsylvania, 17403, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138, United States
USO-Texas Oncology-Central/South Texas
Austin, Texas, 78705, United States
Sarah Cannon Research Institute/SCRI
The Woodlands, Texas, 77380, United States
USO-Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Flinders Medical Centre
Adelaide, 5042, Australia
Bankstown-Lidcombe Hospital
Bankstown, 2200, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Coffs Harbour Health Campus
Coffs Harbour, 2450, Australia
Royal Hobart Hospital
Hobart, 7000, Australia
ICON Cancer Centre - Kurralta Park
Kurralta Park, 5037, Australia
Latrobe Regional Health
Traralgon, 3844, Australia
Calvary Mater Newcastle
Waratah, 2298, Australia
The Perth Blood Institute - West Perth
West Perth, 6005, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Institut Jules Bordet
Anderlecht, 1070, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
UZ Gent
Ghent, 9000, Belgium
Groupe Jolimont
La Louvière, 7100, Belgium
UZ Leuven
Leuven, 3000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
AZ Delta vzw
Roeselare, 8800, Belgium
AZ Nikolaas
Sint-Niklaas, B-9100, Belgium
CHR Verviers - La Tourelle
Verviers, 4800, Belgium
Royal Victoria Regional Health Centre
Barrie, L4M 6M2, Canada
Saskatoon Cancer Centre
Saskatoon, S7N4H4, Canada
Fakultní nemocnice Brno Bohunice
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, 8200, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil, 95107, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, 14033, France
Centre Hospitalier du Mans
Le Mans, 72000, France
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller
Mulhouse, 68100, France
Centre Antoine-Lacassagne
Nice, 06189, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, 37044 Cedex 9, France
MV-Zentrum für Onkologie und Hämatologie
Cologne, 50677, Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, 60389, Germany
OSP Göttingen
Göttingen, 37073, Germany
Onkologisches Ambulanzzentrum Hannover
Hanover, 30171, Germany
Klinikum Aschaffenburg-Alzenau
Hösbach, 63768, Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, 56068, Germany
Evangelismos General Hospital of Athens
Athens, 106 76, Greece
Attikon General University Hospital
Chaïdári, 12462, Greece
G. Papanikolaou General Hospital
Thessaloniki, 570 10, Greece
General Hospital of Athens "Laiko"
Αthens, 11526, Greece
Semmelweis Egyetem
Budapest, 1088, Hungary
Dél-Pesti Centrumkórház
Budapest, 1097, Hungary
Pécsi Tudományegyetem Klinikai Központ
Pécs, 7624, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6725, Hungary
A.O.U.C. Policlinico di Bari
Bari, 70124, Italy
Azienda Ospedaliero Universitaria S.Anna
Cona, 44124, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100, Italy
Azienda Ospedale - Università Padova
Padua, 35128, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, 90146, Italy
AO Santa Maria della Misericordia
Perugia, 06132, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168, Italy
IN VIVO
Bydgoszcz, 85-048, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
AIDPORT Sp. z o.o.
Skórzewo, 60-185, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, 50-367, Poland
Fundeni Clinical Institute
Bucharest, 022328, Romania
Spitalul Clinic Colțea
Bucharest, 030171, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
Institutul Regional de Oncologie
Iași, 700483, Romania
Ovidius Clinical Hospital OCH
Ovidiu, 905900, Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Univerzitna Nemocnica L. Pasteura Kosice
Košice, 040 11, Slovakia
Univerzitna nemocnica Martin
Martin, 036 59, Slovakia
Pusan National University Hospital
Busan, 49241, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345, South Korea
Institut Català d'Oncologia (ICO) - Badalona
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, 08908, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Quironsalud Madrid
Madrid, 28223, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Costa del Sol
Marbella, 29603, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Sakarya University School of Medicine
Adapazarı, 54100, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200, Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, 06620, Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, 07090, Turkey (Türkiye)
Yeditepe Üniversitesi Koşuyolu Hastanesi
Istanbul, 34718, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Kocaeli Üniversitesi
İzmit, 41380, Turkey (Türkiye)
VM Medical Park Mersin Hastanesi
Mersin, 33200, Turkey (Türkiye)
Ondokuz Mayıs Universitesi
Samsun, 55139, Turkey (Türkiye)
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Lincoln County Hospital
Lincoln, LN2 5QY, United Kingdom
Clatterbridge Cancer Centre - Liverpool
Liverpool, L7 8YA, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Part 2 is non-randomized
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2024
First Posted
September 19, 2024
Study Start
January 3, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.