Clinical trial NCT06588478: A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2024-09-19
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory 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 study is expected to last approximately 3 years.


Eligibility criteria: Inclusion Criteria:

* Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
* 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
* 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 and 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 maligna 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Baseline up to 3 years
Secondary outcomes:
measure: Duration of Response
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Irvine
country: United States
facility: City of Hope National Medical Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute (PAMFRI)
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center
state: Florida
city: Newnan
country: United States
facility: City of Hope National Medical Center, Atlanta Cancer Center
state: Georgia
city: Waukee
country: United States
facility: Mission Cancer + Blood
state: Iowa
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center Edgewood
state: Kentucky
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Gulfport
country: United States
facility: Gulfport Memorial Hospital
state: Mississippi
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Eugene
country: United States
facility: Williamette Valley Cancer Institute & Research Center
state: Oregon
city: York
country: United States
facility: Cancer Care Associates Of York
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center
state: Tennessee
city: Austin
country: United States
facility: USO-Texas Oncology-Central/South Texas
state: Texas
city: The Woodlands
country: United States
facility: Sarah Cannon Research Institute/SCRI
state: Texas
city: Hampton
country: United States
facility: USO-Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: USO-Northwest Cancer Specialists, PC
state: Washington
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: ICON Cancer Centre - Kurralta Park
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Traralgon
country: Australia
facility: Latrobe Regional Health
state: Victoria
city: West Perth
country: Australia
facility: The Perth Blood Institute - West Perth
state: Western Australia
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
state: Brabant Wallon
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
state: Bruxelles-Capitale, Région De
city: La Louvière
country: Belgium
facility: Groupe Jolimont
state: Hainaut
city: Verviers
country: Belgium
facility: CHR Verviers - La Tourelle
state: Liège
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta vzw
state: West-Vlaanderen
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: PRague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Praha 10
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Syddanmark
city: Nice
country: France
facility: Centre Antoine-Lacassagne
state: Alpes-Maritimes
city: Mulhouse
country: France
facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace - Hôpital Emile Muller
state: Alsace
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
state: Calvados
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
state: Haute-Garonne
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
state: Indre-et-Loire
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
state: Sarthe
city: Argenteuil
country: France
facility: Centre Hospitalier d'Argenteuil Victor Dupouy
state: Val-d'Oise
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
state: Bayern
city: Frankfurt
country: Germany
facility: Centrum für Hämatologie und Onkologie Bethanien
state: Hessen
city: Goettingen
country: Germany
facility: OSP Göttingen
state: Niedersachsen
city: Hannover
country: Germany
facility: Onkologisches Ambulanzzentrum Hannover
state: Niedersachsen
city: Cologne
country: Germany
facility: MV-Zentrum für Onkologie und Hämatologie
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVO Institut für Versorgungsforschung in der Onkologie
state: Rheinland-Pfalz
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attikí
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Attikí
city: Αthens
country: Greece
facility: General Hospital of Athens "Laiko"
state: Attikí
city: Thessaloniki
country: Greece
facility: G. Papanikolaou General Hospital
state: Thessaloníki
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Dél-Pesti Centrumkórház
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria S.Anna
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
state: Lazio
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Lombardia
city: Bari
country: Italy
facility: A.O.U.C. Policlinico di Bari
state: Puglia
city: Palermo
country: Italy
facility: Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Perugia
country: Italy
facility: AO Santa Maria della Misericordia
state: Umbria
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova
state: Veneto
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonranamdo
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: IN VIVO
state: Kujawsko-pomorskie
city: Kraków
country: Poland
facility: Pratia MCM Krakow
state: Małopolskie
city: Skórzewo
country: Poland
facility: AIDPORT Sp. z o.o.
state: Wielkopolskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
state: Śląskie
city: Bucuresti
country: Romania
facility: Fundeni Clinical Institute
state: București
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital OCH
state: Constanța
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
state: Dolj
city: București
country: Romania
facility: Spitalul Clinic Colțea
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj
city: Iași
country: Romania
facility: Institutul Regional de Oncologie
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Univerzitna Nemocnica L. Pasteura Kosice
state: Košický Kraj
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
state: Žilinský Kraj
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Badalona
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: L'Hospitalet Del Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid, Comunidad De
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Izmit
country: Turkey
facility: Kocaeli Üniversitesi
state: Kocaeli
city: Adapazarı
country: Turkey
facility: Sakarya University School of Medicine
state: Sakarya
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Health Practice and Research Hospitals
city: Antalya
country: Turkey
facility: Memorial Antalya Hospital
city: Istanbul
country: Turkey
facility: Yeditepe Üniversitesi Koşuyolu Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Hastanesi
city: Mersin
country: Turkey
facility: VM Medical Park Mersin Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Universitesi
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: Kent
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
state: Lincolnshire
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: London, City Of
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: London, City Of
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre - Liverpool
city: Swansea
country: United Kingdom
facility: Singleton Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: