RecruitingPhase 2NCT06588478

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

Sponsor

Loxo Oncology, Inc.

Enrollment

249 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a newer type of targeted drug called pirtobrutinib for people with a blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Unlike older drugs in this class, pirtobrutinib can work even when previous treatments have stopped working. **You may be eligible if...** - You have a confirmed diagnosis of CLL or SLL - For Part 1: You have received between 1 and 3 prior treatments, including at least one BTK inhibitor (like ibrutinib or acalabrutinib) - For Part 2: You have not yet received any CLL/SLL treatment and your cancer has a specific chromosome deletion called 17p deletion - You are able to swallow pills - Your general health (ECOG score) is rated 0, 1, or 2 **You may NOT be eligible if...** - You have already been treated with a noncovalent or degrader BTK inhibitor - You had severe bleeding (grade 3 or higher) from a previous BTK inhibitor - Your cancer has transformed into a more aggressive form (Richter's transformation) - You have had another cancer within the last 3 years (some exceptions apply) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Administered Orally.

Locations(133)

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope National Medical Center

Irvine, California, United States

Palo Alto Medical Foundation Research Institute (PAMFRI)

Palo Alto, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Rocky Mountain Cancer Center

Aurora, Colorado, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

City of Hope National Medical Center, Atlanta Cancer Center

Newnan, Georgia, United States

Mission Cancer + Blood

Waukee, Iowa, United States

Saint Elizabeth Medical Center Edgewood

Edgewood, Kentucky, United States

American Oncology Partners, PA

Bethesda, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Gulfport Memorial Hospital

Gulfport, Mississippi, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

East Carolina University

Greenville, North Carolina, United States

Williamette Valley Cancer Institute & Research Center

Eugene, Oregon, United States

Cancer Care Associates Of York

York, Pennsylvania, United States

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States

USO-Texas Oncology-Central/South Texas

Austin, Texas, United States

Sarah Cannon Research Institute/SCRI

The Woodlands, Texas, United States

USO-Virginia Oncology Associates

Hampton, Virginia, United States

Flinders Medical Centre

Adelaide, Australia

Bankstown-Lidcombe Hospital

Bankstown, Australia

Box Hill Hospital

Box Hill, Australia

Coffs Harbour Health Campus

Coffs Harbour, Australia

Royal Hobart Hospital

Hobart, Australia

ICON Cancer Centre - Kurralta Park

Kurralta Park, Australia

Latrobe Regional Health

Traralgon, Australia

Calvary Mater Newcastle

Waratah, Australia

The Perth Blood Institute - West Perth

West Perth, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Institut Jules Bordet

Anderlecht, Belgium

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

UZ Gent

Ghent, Belgium

Groupe Jolimont

La Louvière, Belgium

UZ Leuven

Leuven, Belgium

Clinique Saint Pierre

Ottignies, Belgium

AZ Delta vzw

Roeselare, Belgium

AZ Nikolaas

Sint-Niklaas, Belgium

CHR Verviers - La Tourelle

Verviers, Belgium

Royal Victoria Regional Health Centre

Barrie, Canada

Saskatoon Cancer Centre

Saskatoon, Canada

Fakultní nemocnice Brno Bohunice

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Aarhus Universitetshospital, Skejby

Aarhus, Denmark

Odense Universitetshospital

Odense, Denmark

Centre Hospitalier d'Argenteuil Victor Dupouy

Argenteuil, France

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, France

Centre Hospitalier du Mans

Le Mans, France

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller

Mulhouse, France

Centre Antoine-Lacassagne

Nice, France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

Tours, France

MV-Zentrum für Onkologie und Hämatologie

Cologne, Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt, Germany

OSP Göttingen

Göttingen, Germany

Onkologisches Ambulanzzentrum Hannover

Hanover, Germany

Klinikum Aschaffenburg-Alzenau

Hösbach, Germany

InVO Institut für Versorgungsforschung in der Onkologie

Koblenz, Germany

Evangelismos General Hospital of Athens

Athens, Greece

Attikon General University Hospital

Chaïdári, Greece

G. Papanikolaou General Hospital

Thessaloniki, Greece

General Hospital of Athens "Laiko"

Αthens, Greece

Semmelweis Egyetem

Budapest, Hungary

Dél-Pesti Centrumkórház

Budapest, Hungary

Pécsi Tudományegyetem Klinikai Központ

Pécs, Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Hungary

A.O.U.C. Policlinico di Bari

Bari, Italy

Azienda Ospedaliero Universitaria S.Anna

Cona, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Azienda Ospedale - Università Padova

Padova, Italy

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

Palermo, Italy

AO Santa Maria della Misericordia

Perugia, Italy

AOU Policlinico Umberto I

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy

IN VIVO

Bydgoszcz, Poland

Pratia Onkologia Katowice

Katowice, Poland

Pratia MCM Krakow

Krakow, Poland

AIDPORT Sp. z o.o.

Skórzewo, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Poland

Fundeni Clinical Institute

Bucharest, Romania

Spitalul Clinic Colțea

Bucharest, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

Spitalul Clinic Municipal Filantropia Craiova

Craiova, Romania

Institutul Regional de Oncologie

Iași, Romania

Ovidius Clinical Hospital OCH

Ovidiu, Romania

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

Banská Bystrica, Slovakia

Narodny onkologicky ustav

Bratislava, Slovakia

Univerzitna Nemocnica L. Pasteura Kosice

Košice, Slovakia

Univerzitna nemocnica Martin

Martin, Slovakia

Pusan National University Hospital

Busan, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

Institut Català d'Oncologia (ICO) - Badalona

Badalona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Quironsalud Madrid

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital Costa del Sol

Marbella, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Sakarya University School of Medicine

Adapazarı, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals

Ankara, Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, Turkey (Türkiye)

Yeditepe Üniversitesi Koşuyolu Hastanesi

Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi

Izmir, Turkey (Türkiye)

Kocaeli Üniversitesi

İzmit, Turkey (Türkiye)

VM Medical Park Mersin Hastanesi

Mersin, Turkey (Türkiye)

Ondokuz Mayıs Universitesi

Samsun, Turkey (Türkiye)

Heartlands Hospital

Birmingham, United Kingdom

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Northwick Park Hospital

Harrow, United Kingdom

St James's University Hospital

Leeds, United Kingdom

Lincoln County Hospital

Lincoln, United Kingdom

Clatterbridge Cancer Centre - Liverpool

Liverpool, United Kingdom

Hammersmith Hospital

London, United Kingdom

Maidstone Hospital

Maidstone, United Kingdom

Singleton Hospital

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06588478

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