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

Status: Recruiting
Location: See all (131) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
California
City of Hope National Medical Center
RECRUITING
Duarte
City of Hope National Medical Center
RECRUITING
Irvine
Palo Alto Medical Foundation Research Institute (PAMFRI)
RECRUITING
Palo Alto
Stanford Cancer Center
RECRUITING
Palo Alto
Colorado
Rocky Mountain Cancer Center
NOT_YET_RECRUITING
Aurora
Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center
RECRUITING
Miami
Georgia
City of Hope National Medical Center, Atlanta Cancer Center
RECRUITING
Newnan
Iowa
Mission Cancer + Blood
RECRUITING
Waukee
Kentucky
Saint Elizabeth Medical Center Edgewood
RECRUITING
Edgewood
Massachusetts
Boston Medical Center
RECRUITING
Boston
Maryland
American Oncology Partners of Maryland, PA
RECRUITING
Bethesda
Mississippi
Gulfport Memorial Hospital
RECRUITING
Gulfport
North Carolina
East Carolina University
NOT_YET_RECRUITING
Greenville
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Henderson
New York
Clinical Research Alliance
RECRUITING
Westbury
Oregon
Williamette Valley Cancer Institute & Research Center
NOT_YET_RECRUITING
Eugene
Pennsylvania
Cancer Care Associates Of York
RECRUITING
York
Tennessee
The West Clinic, PLLC dba West Cancer Center
RECRUITING
Germantown
Texas
USO-Texas Oncology-Central/South Texas
NOT_YET_RECRUITING
Austin
Sarah Cannon Research Institute/SCRI
NOT_YET_RECRUITING
The Woodlands
Virginia
USO-Virginia Oncology Associates
NOT_YET_RECRUITING
Hampton
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Bankstown-Lidcombe Hospital
RECRUITING
Bankstown
Box Hill Hospital
RECRUITING
Box Hill
Coffs Harbour Health Campus
RECRUITING
Coffs Harbour
Royal Hobart Hospital
RECRUITING
Hobart
ICON Cancer Centre - Kurralta Park
RECRUITING
Kurralta Park
Latrobe Regional Health
RECRUITING
Traralgon
Calvary Mater Newcastle
RECRUITING
Waratah
The Perth Blood Institute - West Perth
RECRUITING
West Perth
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
AZ Sint-Jan Brugge-Oostende AV
RECRUITING
Bruges
UZ Gent
RECRUITING
Ghent
Groupe Jolimont
RECRUITING
La Louvière
UZ Leuven
RECRUITING
Leuven
Clinique Saint Pierre
RECRUITING
Ottignies
AZ Delta vzw
RECRUITING
Roeselare
AZ Nikolaas
RECRUITING
Sint-niklaas
CHR Verviers - La Tourelle
RECRUITING
Verviers
Canada
Royal Victoria Regional Health Centre
RECRUITING
Barrie
CIUSSS- saguenay-Lac-Saint-Jean
RECRUITING
Chicoutimi
Saskatoon Cancer Centre
NOT_YET_RECRUITING
Saskatoon
Denmark
Aarhus Universitetshospital, Skejby
RECRUITING
Aarhus
Odense Universitetshospital
RECRUITING
Odense
France
Centre Hospitalier d'Argenteuil Victor Dupouy
RECRUITING
Argenteuil
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
RECRUITING
Caen
Centre Hospitalier du Mans
RECRUITING
Le Mans
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller
RECRUITING
Mulhouse
Centre Antoine-Lacassagne
RECRUITING
Nice
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
RECRUITING
Tours
Germany
Klinikum Aschaffenburg-Alzenau
RECRUITING
Aschaffenburg
MV-Zentrum für Onkologie und Hämatologie
NOT_YET_RECRUITING
Cologne
Centrum für Hämatologie und Onkologie Bethanien
RECRUITING
Frankfurt
OSP Göttingen
RECRUITING
Göttingen
Onkologisches Ambulanzzentrum Hannover
RECRUITING
Hanover
InVO Institut für Versorgungsforschung in der Onkologie
RECRUITING
Koblenz
Greece
Evangelismos General Hospital of Athens
RECRUITING
Athens
Attikon General University Hospital
NOT_YET_RECRUITING
Chaïdári
G. Papanikolaou General Hospital
RECRUITING
Thessaloniki
General Hospital of Athens Laiko
RECRUITING
Αthens
Hungary
Dél-Pesti Centrumkórház
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Pécsi Tudományegyetem Klinikai Központ
RECRUITING
Pécs
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
RECRUITING
Szeged
Italy
A.O.U.C. Policlinico di Bari
RECRUITING
Bari
Azienda Ospedaliero Universitaria S.Anna
RECRUITING
Cona
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Azienda Ospedaliero Universitaria Maggiore della Carità
RECRUITING
Novara
Azienda Ospedale - Università Padova
RECRUITING
Padua
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
RECRUITING
Palermo
AO Santa Maria della Misericordia
RECRUITING
Perugia
AOU Policlinico Umberto I
RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING
Roma
Poland
IN VIVO
RECRUITING
Bydgoszcz
Pratia Onkologia Katowice
RECRUITING
Katowice
Pratia MCM Krakow
RECRUITING
Krakow
AIDPORT Sp. z o.o.
RECRUITING
Skórzewo
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun-gun
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
RECRUITING
Seoul
Romania
Fundeni Clinical Institute
RECRUITING
Bucharest
Spitalul Clinic Colțea
RECRUITING
Bucharest
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Spitalul Clinic Municipal Filantropia Craiova
RECRUITING
Craiova
Institutul Regional de Oncologie
RECRUITING
Iași
Ovidius Clinical Hospital OCH
RECRUITING
Ovidiu
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
RECRUITING
Banská Bystrica
Narodny onkologicky ustav
RECRUITING
Bratislava
Univerzitna Nemocnica L. Pasteura Kosice
RECRUITING
Košice
Univerzitna nemocnica Martin
RECRUITING
Martin
Spain
Institut Català d'Oncologia (ICO) - Badalona
RECRUITING
Badalona
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet
RECRUITING
L'hospitalet Del Llobregat
Clinica Universidad de Navarra
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
Hospital Universitario Quironsalud Madrid
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
MD Anderson Cancer Center
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Costa del Sol
RECRUITING
Marbella
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Turkey
Sakarya University School of Medicine
RECRUITING
Adapazarı
Ankara University Health Practice and Research Hospitals
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
RECRUITING
Ankara
Memorial Antalya Hospital
RECRUITING
Antalya
Yeditepe Üniversitesi Koşuyolu Hastanesi
RECRUITING
Istanbul
Ege Universitesi Hastanesi
RECRUITING
Izmir
Kocaeli Üniversitesi
RECRUITING
İzmit
VM Medical Park Mersin Hastanesi
RECRUITING
Mersin
Ondokuz Mayıs Universitesi
RECRUITING
Samsun
United Kingdom
Heartlands Hospital
RECRUITING
Birmingham
The Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Northwick Park Hospital
RECRUITING
Harrow
St James's University Hospital
RECRUITING
Leeds
Lincoln County Hospital
RECRUITING
Lincoln
Clatterbridge Cancer Centre - Liverpool
RECRUITING
Liverpool
Hammersmith Hospital
RECRUITING
London
Maidstone Hospital
RECRUITING
Maidstone
Singleton Hospital
RECRUITING
Swansea
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2028-12
Participants
Target number of participants: 249
Treatments
Active_comparator: Pirtobrutinib Standard Dose (Dose 1)-Part 1
Pirtobrutinib administered orally.
Experimental: Pirtobrutinib Dose 2-Part 1
Pirtobrutinib administered orally.
Experimental: Pirtobrutinib Dose 3-Part 1
Pirtobrutinib administered orally.
Experimental: Pirtobrutinib Standard Dose-Part 2
Pirtobrutinib administered orally.
Sponsors
Collaborators: Eli Lilly and Company
Leads: Loxo Oncology, Inc.

This content was sourced from clinicaltrials.gov

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