NCT06588478RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 249 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 3 Jan 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Loxo Oncology, Inc.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT06588478
- EU CT number
- 2024-515689-15-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 249
- From 3 Jan 2025 to the primary completion date, Jun 2028
- 129 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Have known or suspected history of central nervous system involvement by CLL/SLL
Other
- Have known or suspected Richter's transformation
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (129)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Bankstown-Lidcombe Hospital Coordinator of this site? Confirm its status | Bankstown | Australia | Recruiting |
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Coffs Harbour Health Campus Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Recruiting |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Recruiting |
| Icon Cancer Centre Kurralta Park Coordinator of this site? Confirm its status | Kurralta Park | Australia | Recruiting |
| Latrobe Regional Health Coordinator of this site? Confirm its status | Traralgon | Australia | Recruiting |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| The Perth Blood Institute - West Perth Coordinator of this site? Confirm its status | West Perth | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| AZ Sint-Jan Brugge-Oostende AV Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Groupe Jolimont Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Clinique Saint Pierre Coordinator of this site? Confirm its status | Ottignies | Belgium | Recruiting |
| AZ Delta vzw Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| AZ Nikolaas Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Recruiting |
| CHR Verviers - La Tourelle Coordinator of this site? Confirm its status | Verviers | Belgium | Recruiting |
| Royal Victoria Regional Health Centre Coordinator of this site? Confirm its status | Barrie | Canada | Recruiting |
| Saskatoon Cancer Centre Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
| Fakultní nemocnice Brno Bohunice Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Active, not recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| MV-Zentrum für Onkologie und Hämatologie Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Centrum für Hämatologie und Onkologie Bethanien Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| OSP Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Recruiting |
| Onkologisches Ambulanzzentrum Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Klinikum Aschaffenburg-Alzenau Coordinator of this site? Confirm its status | Hösbach | Germany | Recruiting |
| InVO Institut für Versorgungsforschung in der Onkologie Coordinator of this site? Confirm its status | Koblenz | Germany | Recruiting |
| Aarhus Universitetshospital, Skejby Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Odense Universitetshospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Català d'Oncologia - L'Hospitalet Coordinator of this site? Confirm its status | L'Hospitalet Del Llobregat | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Centre Hospitalier d'Argenteuil Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil | France | Recruiting |
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre Hospitalier du Mans Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Hôpital Emile Muller Coordinator of this site? Confirm its status | Mulhouse | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| The Beatson West of Scotland Cancer Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Northwick Park Hospital Coordinator of this site? Confirm its status | Harrow | United Kingdom | Recruiting |
| St James's University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| Lincoln County Hospital Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Recruiting |
| Clatterbridge Cancer Centre - Liverpool Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Singleton Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Recruiting |
| Evangelismos General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Attikon General University Hospital Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| G. Papanikolaou General Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| General Hospital of Athens "Laiko" Coordinator of this site? Confirm its status | Αthens | Greece | Recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Dél-Pesti Centrumkórház Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Pécsi Tudományegyetem Klinikai Központ Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| A.O.U.C Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Azienda Ospedaliero Universitaria S.Anna Coordinator of this site? Confirm its status | Cona | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| AO Santa Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| AOU Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun-gun | South Korea | Recruiting |
| The Catholic University of Korea Yeouido St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| IN VIVO Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul Oncologic Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Municipal Filantropia Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Institutul Regional de Oncologie Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Ovidius Clinical Hospital OCH Coordinator of this site? Confirm its status | Ovidiu | Romania | Recruiting |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Recruiting |
| Narodny onkologicky ustav Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Univerzitna nemocnica L. Pasteura Kosice Coordinator of this site? Confirm its status | Košice | Slovakia | Recruiting |
| Univerzitna nemocnica Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Recruiting |
| Rocky Mountain Cancer Center Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| USO-Texas Oncology-Central/South Texas Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| American Oncology Partners, PA Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Ironwood Cancer & Research Centers Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Saint Elizabeth Medical Center Edgewood Coordinator of this site? Confirm its status | Edgewood | United States | Recruiting |
| Williamette Valley Cancer Institute & Research Center Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Gulfport Memorial Hospital Coordinator of this site? Confirm its status | Gulfport | United States | Recruiting |
| USO-Virginia Oncology Associates Coordinator of this site? Confirm its status | Hampton | United States | Recruiting |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Henderson | United States | Recruiting |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| City of Hope National Medical Center, Atlanta Cancer Center Coordinator of this site? Confirm its status | Newnan | United States | Recruiting |
| Palo Alto Medical Foundation Research Institute (PAMFRI) Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Stanford Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Sarah Cannon Research Institute/SCRI Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| Mission Cancer Blood Coordinator of this site? Confirm its status | Waukee | United States | Recruiting |
| Cancer Care Associates of York Coordinator of this site? Confirm its status | York | United States | Recruiting |
| Sakarya University School of Medicine Coordinator of this site? Confirm its status | Adapazarı | Turkey (Türkiye) | Recruiting |
| Ankara University Health Practice and Research Hospitals Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Memorial Antalya Hospital Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
| Yeditepe Üniversitesi Koşuyolu Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Ege Universitesi Hastanesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Kocaeli Üniversitesi Coordinator of this site? Confirm its status | İzmit | Turkey (Türkiye) | Recruiting |
| VM Medical Park Mersin Hastanesi Coordinator of this site? Confirm its status | Mersin | Turkey (Türkiye) | Recruiting |
| Ondokuz Mayıs Universitesi Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.