Clinical trial NCT04666038: Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Official title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: Hematologic Disease
Lymphoma, non-Hodgkin's
Lymphoma, B-cell
Lymphoma
Bruton's tyrosine kinase inhibitor
Ibrutinib
Acalabrutinib
Zanubrutinib
Pirtobrutinib
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2020-12-14
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized in 1:1 into Arm A or Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A. Patients who discontinue treatment for toxicity may still be evaluated for cross over at the time of IRC-confirmed PD.
Primary purpose: TREATMENT

Brief summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Detailed description: This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A or Arm B.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria.
* Previously treated with a covalent BTK inhibitor.
* Eastern Cooperative Oncology Group (ECOG) 0-2.
* Absolute neutrophil count ≥ 0.75 × 10\^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10\^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement.
* Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement.
* Platelets ≥ 50 × 10\^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10\^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count \< 30 x 10\^9/L are excluded.
* AST and ALT ≤ 3.0 x upper limit of normal (ULN).
* Total bilirubin ≤ 1.5 x ULN.
* Estimated creatinine clearance of ≥ 30 mL/min.

Exclusion Criteria:

* Known or suspected Richter's transformation at any time preceding enrollment.
* Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
* Ongoing drug-induced liver injury.
* Active uncontrolled auto-immune cytopenia.
* Significant cardiovascular disease.
* History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days.
* Active hepatitis B or hepatitis C.
* Known active cytomegalovirus (CMV) infection.
* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
* Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
* Clinically significant active malabsorption syndrome or inflammatory bowel disease
* Prior exposure to non-covalent (reversible) BTK inhibitor.
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
* Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers.
* Vaccination with a live vaccine within 28 days prior to randomization.
* Patients with the following hypersensitivity:

  1. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
  2. Prior significant hypersensitivity to rituximab.

Primary outcomes:
measure: Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
timeFrame: Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)
Secondary outcomes:
measure: PFS Assessed by Investigator
timeFrame: Randomization to Disease Progression or Death Due to Any Cause (Up to 36 Months)
measure: Overall Survival (OS)
timeFrame: Randomization to Death from Any Cause (Up to 36 months)
measure: Time to Next Treatment (TTNT)
timeFrame: Randomization to Subsequent Anticancer Therapy, Therapy of Pirtobrutinib or Death Due to Any Cause (Up to 36 Months)
measure: Event Free Survival (EFS)
timeFrame: Randomization to Disease Progression, Subsequent Anticancer Therapy, Unacceptable Toxicity Leading to Treatment Discontinuation, or Death Due to Any Cause (Up to 36 Months)
measure: Percentage of Participants With Overall Response Rate (ORR) Assessed by Investigator
timeFrame: Randomization to Subsequent Anticancer Therapy, Disease Progression or Death Due to Any Cause (Up to 36 Months)
measure: Time to Worsening (TTW) of CLL/SLL Related Symptoms
timeFrame: Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)
measure: Time to Worsening (TTW) of Physical Function
timeFrame: Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, P.C.
state: Alabama
city: Mobile
country: United States
facility: Mitchell Cancer Institute -University of South Alabama
state: Alabama
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, P.C. - HOPE
state: Arizona
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: California Research Institute
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants, PA
state: Delaware
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida -St Augustine
state: Florida
city: Tamarac
country: United States
facility: Oncology-Hematology Associates of West Broward
state: Florida
city: Marietta
country: United States
facility: WellStar Health System
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists-Niles
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Paducah
country: United States
facility: Mercy Health-Paducah Medical Oncology and Hematology
state: Kentucky
city: New Orleans
country: United States
facility: Cancer Center Office of Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Greenebaum Comprehensive Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Saint Paul
country: United States
facility: Minnesota Oncology/Hematology PA
state: Minnesota
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology
state: Nebraska
city: Brick
country: United States
facility: New Jersey Center for Cancer Research
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: Gainesville
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia Inc
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: The St. George Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Ingham Institute of Medical Research
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Oberösterreich
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
state: Osterreich
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Verviers
country: Belgium
facility: CHR Verviers-Onco
state: Liege
city: Sint-Niklaas
country: Belgium
facility: VITAZ
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West Flanders
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Haine-Saint-Paul
country: Belgium
facility: Groupe Jolimont
city: Herentals
country: Belgium
facility: AZ St-Elisabeth
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre Ottignies
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital (Ontario)
state: Ontario
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Xicheng District
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: Gansu Province Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan Province People's Hospital
state: Hainan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Ürümqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Linhai
country: China
facility: Zhejiang Provincial Taizhou Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Blood Institute of the Chinese Academy of Medical science
city: Split
country: Croatia
facility: University Hospital Split
city: Zagreb
country: Croatia
facility: Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Grenoble
country: France
facility: CHU De Grenoble Hopital Albert Michallon
state: Cedex 09
city: Bobigny
country: France
facility: Hospital AVICENNE
state: Cedex
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
state: Cedex
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
state: La Roche Sur Yon
city: Nîmes
country: France
facility: Chu Nimes/Institut De Cancerologie Du Gard
state: Nimes
city: Rouen
country: France
facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
state: Seine-Maritime
city: Tours
country: France
facility: CHRU De Tours
state: Tours Cedex 9
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
city: Brest cedex
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille cedex
country: France
facility: Hopital Saint Vincent De Paul
city: Perpignan
country: France
facility: Ch Perpignan
city: Politiers
country: France
facility: Pole Regionalde Cancérologie(CHU de Poitiers)
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Kerpener
country: Germany
facility: Uniklinik Köln
state: Köln
city: Langenbeckstraße 1
country: Germany
facility: Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
state: Mainz
city: Koelner Platz 1
country: Germany
facility: München Klinik Schwabing
state: München
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Lübecker Onkologische Schwerpunktpraxis
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Pecs
country: Hungary
facility: University of Pecs 1st. Internalmedicin Clinic Dept
city: Dublin 7
country: Ireland
facility: Mater Misericordiae Hospital
city: Dublin 8
country: Ireland
facility: St James's Hosptial
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Netanya
country: Israel
facility: Laniado Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Haifa
country: Israel
facility: Carmel Hospital
state: Ḥeifā
city: Viale Orazio Flacco
country: Italy
facility: Irccs Istituto Tumori Giovanni Paolo Ii
state: Bari
city: Monza (MB) -Settore E
country: Italy
facility: ASST-Monza -U.O Ematologia Adulti
state: Piano 2
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: PI
city: Rionero In Vulture
country: Italy
facility: Irccs Crob
state: Potenza
city: Vicenza
country: Italy
facility: AULSS8 Berica-Ospedale S.Bortolo
state: Veneto
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Brescia
country: Italy
facility: ASST Spedali Civili - Università degli Studi
city: Catania
country: Italy
facility: A.O.U. Policlinico G.Rodolico - S. Marco
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese Ciaccio
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: Ospedale Papardo
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
city: Modena
country: Italy
facility: A.O.U. di Modena
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Torino
country: Italy
facility: A.O.U. Citta' della Salute e della Scienza di Torino
city: Tricase
country: Italy
facility: Az. Osp. "Card G Panico"
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma
city: Nagoya
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Isehara
country: Japan
facility: Tokai University Hospital- Isehara Campus
state: Kanagawa
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Sendai-shi
country: Japan
facility: NHO Sendai Medical Center
state: Miyagi-Ken
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka Sayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Fukoka-ken
country: Japan
facility: JCHO Kyushu Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Hospital
state: Incheon-gwangyeoksi [Incheon]
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, Korea
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seocho-Gu
country: Korea, Republic of
facility: The Catholic University of Korea-Seoul St. Mary's Hospital
state: Seoul
city: Busan
country: Korea, Republic of
facility: Inje Univ Busan Paik Hospital
city: Iwaszkiewicza 5
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
state: Legnica
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
state: Lubelskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.
state: Pomorskie
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Walbrzych
country: Poland
facility: Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny Klinika
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
state: Omskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
city: Saint Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St-Petersburg State Medical University
city: Sochi
country: Russian Federation
facility: Oncology Dispensary #2 of Krasnodar Region
city: Singapore
country: Singapore
facility: Gleneagles Medical Centre
state: Central Singapore
city: Hospitalet De Llobregat
country: Spain
facility: Hospital Duran I Reynals
state: Barcelona
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
state: Castilla La Mancha
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostel
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
state: Madrid, Comunidad De
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
state: Planta Baja
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor-INTERNAL MED
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santander
country: Spain
facility: Hospital Universitario Marques De Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Vitoria
country: Spain
facility: Hospital Universitario de Alava
city: Bellinzona
country: Switzerland
facility: Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale
state: Svizzera
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Taichung
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan, (r.o.c.)
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Mamak
country: Turkey
facility: Ankara University Medicine Hospital
state: Ankara
city: Faith
country: Turkey
facility: Istanbul University Istanbul Medicine Faculty
state: Istanbul
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Medicine
state: Melikgazi
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
state: Yenimahalle
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeen City
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital
state: Cornwall
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
city: London
country: United Kingdom
facility: University College London Hospitals
state: Greater London
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
state: Norfolk
city: Swansea
country: United Kingdom
facility: Singleton Hospital
state: Sa2 8qa
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Livingston
country: United Kingdom
facility: St Johns Hospital at Howden
state: West Lothian
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
city: Newmarket
country: United Kingdom
facility: GenesisCare Cambridge
Study officials:
affiliation: Loxo Oncology, Inc.
name: Marisa Hill, MD
role: STUDY_DIRECTOR
References: