A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314)

January 24, 2024 updated by: Loxo Oncology, Inc.

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

650

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming
        • Principal Investigator:
          • María Del Rosario Custidiano
        • Contact:
          • Phone Number: +541132218930
      • Cordoba, Argentina, X5000GXA
        • Recruiting
        • Sanatorio Allende-Cordoba
        • Contact:
          • Phone Number: +54 9 351 6657 014
        • Principal Investigator:
          • María Sol Jarchum
      • Cordoba, Argentina, X5016KEH
        • Recruiting
        • Hospital Privado Centro Medico de Cordoba SA
        • Contact:
          • Phone Number: 0351-676 5752
        • Principal Investigator:
          • Gabriela Sturich
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
        • Contact:
          • Phone Number: +54 (342) 4055449
        • Principal Investigator:
          • Daniel Bar
    • Buenos Aires
      • Autonoma De Buenos Aires, Buenos Aires, Argentina, 1114
        • Recruiting
        • Fundaleu
        • Contact:
          • Phone Number: +54 11 4877 1075
        • Principal Investigator:
          • Carolina Pavlovsky
      • Mar Del Plata, Buenos Aires, Argentina, B7602CBM
        • Recruiting
        • Hospital Privado de Comunidad
        • Principal Investigator:
          • Fernando Santini
        • Contact:
          • Phone Number: 542234990000
    • Ciudad Autónoma De Buenos Aire
      • ABB, Ciudad Autónoma De Buenos Aire, Argentina, 1199
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Phone Number: +54 9 4959 0200 ext 4485
        • Principal Investigator:
          • Dorotea Fantl
  • Australia
      • West Perth, Australia, 6005
        • Recruiting
        • The Perth Blood Institute
        • Contact:
          • Phone Number: 08 9200 5300
        • Principal Investigator:
          • Ross Baker
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Principal Investigator:
          • Anna Johnston
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Principal Investigator:
          • Constantine Tam
        • Contact:
          • Phone Number: 61392762732
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Sunshine Hospital
        • Contact:
          • Phone Number: +0383451333
        • Principal Investigator:
          • William Renwick
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research
        • Principal Investigator:
          • Peter Thian Guan Tan
        • Contact:
          • Phone Number: 61 8 6279 9466
  • Austria
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz Gmbh Elisabethinen
        • Principal Investigator:
          • Michael Girschikofsky
        • Contact:
          • Phone Number: 43 732 7676
      • Linz, Austria, 4010
        • Recruiting
        • Krankenhaus Barmherzige Schwestern Linz
        • Principal Investigator:
          • Manuel Orlinger
        • Contact:
          • Phone Number: +4373276774894
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz
        • Contact:
          • Phone Number: 4373276774894
        • Principal Investigator:
          • Manuel Orlinger
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
        • Contact:
          • Phone Number: +3216346880
        • Principal Investigator:
          • Ann Janssens
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Recruiting
        • VITAZ
        • Principal Investigator:
          • Vanessa Van Hende
        • Contact:
          • Phone Number: +32 3 760 2985
    • West Flanders
      • Roeselare, West Flanders, Belgium, 8800
        • Recruiting
        • AZ Delta
        • Principal Investigator:
          • Lien Deleu
        • Contact:
          • Phone Number: +3251237322
  • Brazil
      • Cascavel, Brazil, 85806-300
        • Recruiting
        • Hospital Uopeccan - Centro de Pesquisa Clinica
        • Contact:
          • Phone Number: +55 (45) 9 9135 1056
        • Principal Investigator:
          • Ademar Dantas da Cunha Junior
      • Sao Paulo, Brazil, 01323-001
        • Recruiting
        • Hospital Beneficencia Portuguesa de Sao Paulo
        • Principal Investigator:
          • Danielle Leão Cordeiro de Farias
        • Contact:
          • Phone Number: +556239454769
      • Sao Paulo, Brazil, 08270-070
        • Recruiting
        • Hospital Santa Marcelina
        • Principal Investigator:
          • Patricia de Paulo Giacon
        • Contact:
          • Phone Number: +551122173766
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
        • Principal Investigator:
          • Raphael Costa Bandeira de Melo
        • Contact:
          • Phone Number: 551145737631
    • Minas Gera
      • Belo Horizonte, Minas Gera, Brazil, 30130-100
        • Recruiting
        • Centro de Pesquisas Clínicas do Hospital das Clínicas da UFMG - Ebserh
        • Contact:
          • Phone Number: +55 31 33079089
        • Principal Investigator:
          • Sergio Silva
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Recruiting
        • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
        • Principal Investigator:
          • Joao Samuel de Holanda Farias
        • Contact:
          • Phone Number: +5541999846033
      • Curitiba, Paraná, Brazil, 80810-050
        • Recruiting
        • Centro Integrado de Oncologia de Curitiba
        • Principal Investigator:
          • Michel Michels de Oliveira
        • Contact:
          • Phone Number: +554130242421
      • Curitiba, Paraná, Brazil, 80810-050
        • Recruiting
        • CIONC-Centro Integrado de Oncologia de Curitiba
        • Principal Investigator:
          • Michel Michels de Oliveira
        • Contact:
          • Phone Number: +554130242421
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
        • Recruiting
        • Instituto do Câncer - Hospital São Vicente de Paulo
        • Principal Investigator:
          • Moema Nene Santos
        • Contact:
          • Phone Number: +555421034130
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
        • Recruiting
        • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
        • Principal Investigator:
          • Marcelo Capra
        • Contact:
          • Phone Number: +555133072943
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Recruiting
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
        • Principal Investigator:
          • Rafael Dezen Gaiolla
        • Contact:
          • Phone Number: +551438801663
      • Campinas, Sao Paulo, Brazil, 13083-878
        • Recruiting
        • Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
        • Principal Investigator:
          • Fernando Vieira Pericole de Souza
        • Contact:
          • Phone Number: +551935218734
      • Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
        • Principal Investigator:
          • Carlos Eduardo Miguel
        • Contact:
          • Phone Number: +551732015000
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundacao Pio XII - Hospital de Cancer de Barretos
        • Principal Investigator:
          • Nelson Siqueira de Castro
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
        • Contact:
          • Phone Number: 16 98112-6986
        • Principal Investigator:
          • Diego Villa Clé
      • Santo André, São Paulo, Brazil, 09060-650
        • Recruiting
        • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
        • Contact:
          • Phone Number: +55.11.4993-5491
        • Principal Investigator:
          • Debora Rodrigues Bonito
  • Canada
      • Québec, Canada, G1J 1Z4
        • Recruiting
        • Hopital de L'enfant Jesus
        • Contact:
          • Phone Number: 418-525-4444 ext. 0
        • Principal Investigator:
          • Robert Delage
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • Cancer Care Manitoba
        • Principal Investigator:
          • Versha Banerji
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Principal Investigator:
          • Derek Nay
        • Contact:
          • Phone Number: 7057395661
  • Chile
    • IX Región
      • Temuco, IX Región, Chile, 4780000
        • Recruiting
        • Sociedad de Investigaciones Medicas Limitada
        • Contact:
          • Phone Number: +56974316500
        • Principal Investigator:
          • Eduardo Yañez
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8320000
        • Recruiting
        • CECIM Biocinetic
        • Contact:
          • Phone Number: +56958263308
        • Principal Investigator:
          • Alexander Arellano
    • Santiago
      • Providencia, Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA
        • Contact:
          • Phone Number: +56997890202
        • Principal Investigator:
          • Alejandro Berkovits
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 2520000
        • Recruiting
        • Centro de Investigaciones Clínicas Viña del Mar (CIC)
        • Contact:
          • Phone Number: 56 940254875
        • Principal Investigator:
          • Christine Rojas Hopkins
  • China
      • Haikou, China, 570311
        • Recruiting
        • Hainan General Hospital
        • Principal Investigator:
          • Lie Lin
        • Contact:
          • Phone Number: +86 13976595976
      • Hangzhou, China, 310003
        • Recruiting
        • First Affiliated Hosp of College of Med, Zhejiang University
        • Contact:
          • Phone Number: 86 13505716779
        • Principal Investigator:
          • Jie Jin
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
          • Phone Number: +86 18627091655
        • Principal Investigator:
          • Guohui Cui
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Xingbing Wang
        • Contact:
          • Phone Number: +8613856007984
      • Hefei, Anhui, China, 231200
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Phone Number: +86 13855147434
        • Principal Investigator:
          • Zhai Zhimin
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Principal Investigator:
          • He Huang
        • Contact:
          • Phone Number: +862087343356
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital
        • Contact:
          • Phone Number: +8613802426709
        • Principal Investigator:
          • Xutao Guo
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
          • Phone Number: +86 13507711671
        • Principal Investigator:
          • Hong Cen
    • Hubei
      • Wuhan City, Hubei, China, 430030
        • Recruiting
        • Wu Han Tongji Hospital
        • Principal Investigator:
          • Xiaoxi Zhou
        • Contact:
          • Phone Number: 13871454649
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Phone Number: +86 13975879796
        • Principal Investigator:
          • Hui Zhou
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The 2nd Xiangya Hospital of Central South University
        • Principal Investigator:
          • Hongling Peng
        • Contact:
          • Phone Number: +8613975806137
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital Of Nanchang University
        • Principal Investigator:
          • Fei Li
        • Contact:
          • Phone Number: +86 13970038386
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Provincial Cancer Hospital
        • Contact:
          • Phone Number: 86 13607045741
        • Principal Investigator:
          • Yuerong Shuang
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
        • Principal Investigator:
          • Junmin Li
        • Contact:
          • Phone Number: 86 13817712211
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Phone Number: +862164036901
        • Principal Investigator:
          • Junning Cao
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Phone Number: 13920350233
        • Principal Investigator:
          • Rong Fu
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Blood Institute of the Chinese Academy of Medical science
        • Contact:
          • Phone Number: 15900265415
        • Principal Investigator:
          • Shuhua Yi
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Recruiting
        • The Affiliated Cancer Hospital of XinJiang Medical University
        • Principal Investigator:
          • Shujuan Wen
        • Contact:
          • Phone Number: +8618160631686
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The second affiliated hospital of zhejiang university school of medicine
        • Contact:
          • Phone Number: 8615967109905
        • Principal Investigator:
          • Zhang Xiaohong
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • The Fourth Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Phone Number: +8613805793551
        • Principal Investigator:
          • Dan Chen
  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • Fakultni nemocnice Brno
        • Principal Investigator:
          • Jiri Mayer
        • Contact:
          • Phone Number: (+420) 532 233 642
      • Hradec Kralove, Czechia, 50005
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Principal Investigator:
          • Martin Simkovic
        • Contact:
          • Phone Number: +420495834851
      • Ostrava-Poruba, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava
        • Contact:
          • Phone Number: (+420) 597 372 749
        • Principal Investigator:
          • Jana Mihalyova
      • Plzen - Lochotin, Czechia, 30460
        • Recruiting
        • Fakultní nemocnice Plzen
        • Contact:
          • Phone Number: (+420) 377 103 722
        • Principal Investigator:
          • Daniel Lysak
      • Praha 10, Czechia, 100 34
        • Recruiting
        • Fakultni nemocnice Kralovske Vinohrady
        • Principal Investigator:
          • Jan Novak
        • Contact:
          • Phone Number: (+420) 267 163 530
      • Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna Fakultni Nemocnice V Praze
        • Contact:
          • Phone Number: (+420)224962527
        • Principal Investigator:
          • Marek Trneny
  • France
      • La Roche sur Yon, France, 85000
        • Recruiting
        • CHD Vendee
        • Principal Investigator:
          • Bruno Villemagne
        • Contact:
          • Phone Number: +33251446173
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier Du Mans
        • Contact:
          • Phone Number: +33 2.43.43.29.59
        • Principal Investigator:
          • Kamel Laribi
      • Limoges, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)
        • Contact:
          • Phone Number: +33(0)555 05 88 22
        • Principal Investigator:
          • Nataliya Dmutruk
      • Rouen Cedex, France, 76038
        • Recruiting
        • Centre Henri Becquerel
        • Principal Investigator:
          • Stephane Lepretre
        • Contact:
          • Phone Number: + 33 2 32 08 22 23
    • Cedex
      • Pierre Benite, Cedex, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • Phone Number: +33 4 78 86 43 07
        • Principal Investigator:
          • Emmanuelle Ferrant
    • Cedex 1
      • Nantes, Cedex 1, France, 44093
        • Recruiting
        • CHU de Nantes - Hotel Dieu
        • Principal Investigator:
          • Anne Lok
        • Contact:
          • Phone Number: +33 2 40 08 32 71
    • Cedex 13
      • Paris, Cedex 13, France, 75651
        • Recruiting
        • Hopital de la Pitie Salpetriere
        • Contact:
          • Phone Number: +33 1 42 16 15 96
        • Principal Investigator:
          • Damien Roos-Weil
    • Cedex 9
      • Rennes, Cedex 9, France, 35033
        • Recruiting
        • Hôpital de Pontchaillou
        • Principal Investigator:
          • Sophie De Guibert
        • Contact:
          • Phone Number: +33 299 28 4291
    • Nice Cedex 2
      • Nice, Nice Cedex 2, France, 06189
        • Recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Phone Number: 33 (0)4 92 03 10 35
        • Principal Investigator:
          • Daniel Re
    • Tours Cedex 9
      • Tours, Tours Cedex 9, France, 37044
        • Recruiting
        • CHRU De Tours
        • Principal Investigator:
          • Caroline Dartigeas
        • Contact:
          • Phone Number: +33 2 47 47 37 12
  • Germany
    • Baden
      • Ulm, Baden, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Contact:
          • Phone Number: +4973150056000
        • Principal Investigator:
          • Stephan Stilgenbauer
    • Baden Wuerttemberg
      • Tübingen, Baden Wuerttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Principal Investigator:
          • Stefan Wirths
        • Contact:
          • Phone Number: +4970712986017
    • Köln
      • Kerpener, Köln, Germany, 50937
        • Recruiting
        • Uniklinik Köln
        • Principal Investigator:
          • Paula Cramer
        • Contact:
          • Phone Number: 49 221 478-88202
    • Nordrhein Westfalen
      • Dortmund, Nordrhein Westfalen, Germany, 44263
        • Recruiting
        • GEFOS (Gesellschaft für onkologische Studien) Dortmund mbH
        • Principal Investigator:
          • Clemens Schulte
        • Contact:
          • Phone Number: +492312069011
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Tu Dresden
        • Principal Investigator:
          • Johannes Schetelig
        • Contact:
          • Phone Number: +493514584190
    • Sachsen Anhalt
      • Dresden, Sachsen Anhalt, Germany, 01307
        • Recruiting
        • Gemeinschaftspraxis Haematologie und Onkologie
        • Principal Investigator:
          • Lutz Jacobasch
        • Contact:
          • Phone Number: +493514472340
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
        • Recruiting
        • Gemeinschaftspraxis für Hämatologie and Onkologie
        • Principal Investigator:
          • Kathleen Jentsch-Ulrich
        • Contact:
          • Phone Number: 03915096890
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem
        • Principal Investigator:
          • Árpád Illes
        • Contact:
          • Phone Number: +3652255196
      • Nyiregyhaza, Hungary, 4400
        • Recruiting
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
        • Principal Investigator:
          • Laszlo Rejto
        • Contact:
          • Phone Number: 36703163930
      • Szombathely, Hungary, 9700
        • Recruiting
        • Markusovszky Egyetemi Oktatókórház
        • Contact:
          • Phone Number: 3694515671
        • Principal Investigator:
          • Mark Plander
  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Health Care Campus
        • Principal Investigator:
          • Riva Fineman
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Principal Investigator:
          • Neta Goldschmidt
      • Petach-Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center-Beilinson Campus
        • Principal Investigator:
          • Ronit Gurion
        • Contact:
          • Phone Number: +97239378008
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Chaim Sheba Medical Center
        • Principal Investigator:
          • Ohad Benjamini
        • Contact:
          • Phone Number: 972526669155
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Yair Herishanu
      • Tel Hashomer, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Ohad Benjamini
        • Contact:
          • Phone Number: +97235302386
      • Yerushalayim, Israel, 22100
        • Recruiting
        • Hadassah University Hospital - Ein Kerem
        • Principal Investigator:
          • Neta Goldschmidt
        • Contact:
          • Phone Number: +97226777748
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
        • Principal Investigator:
          • Gioacchino Catania
        • Contact:
          • Phone Number: +393287768573
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
        • Principal Investigator:
          • Pier Luigi Zinzani
        • Contact:
          • Phone Number: +39512144042
      • Milano, Italy, 20141
        • Recruiting
        • Ieo Istituto Europeo Di Oncologia
        • Principal Investigator:
          • Enrico Derenzini
        • Contact:
          • Phone Number: +390516363680
      • Milano, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Principal Investigator:
          • Paolo Ghia
        • Contact:
          • Phone Number: 39 02 26434797
      • Milano, Italy, 20122
        • Recruiting
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
          • Phone Number: +39255033421
        • Principal Investigator:
          • Veronica Mattiello
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliera Di Parma
        • Contact:
          • Phone Number: 0039 0521703962
        • Principal Investigator:
          • Filomena Russo
      • Reggio Emilia, Italy, 42122
        • Recruiting
        • Azienda Unita Sanitaria Locale di Reggio Emilia
        • Principal Investigator:
          • Fiorella Ilariucci
        • Contact:
          • Phone Number: +39522296623
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche Di Verona S.R.L.
        • Principal Investigator:
          • Issaco Ferrarini
        • Contact:
          • Phone Number: +393393847092
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
        • Recruiting
        • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
        • Contact:
          • Phone Number: +39543739100
        • Principal Investigator:
          • Gerardo Musuraca
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
        • Principal Investigator:
          • Pio Manlio Mirko Frascione
        • Contact:
          • Phone Number: +39119933250
  • Japan
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
        • Principal Investigator:
          • Hiro Tatetsu
        • Contact:
          • Phone Number: 81963442111
      • Yamagata, Japan, 990-2331
        • Recruiting
        • Yamagata University Hospital
        • Contact:
          • Phone Number: +81 (23) 633 1122
        • Principal Investigator:
          • Tomomi Tobai
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1143
        • Recruiting
        • Tokai University Hospital- Isehara Campus
        • Contact:
          • Phone Number: +81-463-93-5083
        • Principal Investigator:
          • Yoshiaki Ogawa
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje Univ Busan Paik Hospital
        • Contact:
          • Phone Number: +82-51-890-6407
        • Principal Investigator:
          • Won Sik Lee
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Phone Number: +82234106548
        • Principal Investigator:
          • Won Seog Kim
    • Seoul
      • Seocho-Gu, Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea-Seoul St. Mary's Hospital
        • Principal Investigator:
          • Ki-Seong Eom
        • Contact:
          • Phone Number: 02-2228-6056
    • Seoul, Korea
      • Seoul, Seoul, Korea, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Phone Number: 82 2 2072 3079
        • Principal Investigator:
          • Sung-Soo Yoon
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital
        • Principal Investigator:
          • Fionnuala Fagan
        • Contact:
          • Phone Number: +6434740999
      • Hamilton, New Zealand, 3200
        • Recruiting
        • Waikato Hospital
        • Principal Investigator:
          • Shahid Islam
        • Contact:
          • Phone Number: +6478398899
      • Otahuhu, New Zealand, 2025
        • Recruiting
        • Middlemore Hospital
        • Contact:
          • Phone Number: +64948689207074
        • Principal Investigator:
          • James Liang
    • Otago
      • Dunedin, Otago, New Zealand, 9001
        • Recruiting
        • University of Otago School of Medicine
        • Principal Investigator:
          • Fionnuala Fagan
    • Wellington
      • Newtown, Wellington, New Zealand, 6021
        • Recruiting
        • P3 Research
        • Contact:
          • Phone Number: 6443855999
        • Principal Investigator:
          • Robert Weinkove
  • Poland
      • Biała Podlaska, Poland, 21500
        • Recruiting
        • KO-MED Centra Kliniczne
        • Principal Investigator:
          • Piotr Centkowski
        • Contact:
          • Phone Number: 48 83 414 71 07
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
        • Contact:
          • Phone Number: +48508508810
        • Principal Investigator:
          • Jaroslaw Czyz
      • Katowice, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice
        • Principal Investigator:
          • Sabastian Grosicki
        • Contact:
          • Phone Number: +48 600 388 282
      • Krakow, Poland, 30-510
        • Recruiting
        • Pratia MCM Krakow
        • Contact:
          • Phone Number: +48 602 338 290
        • Principal Investigator:
          • Wojciech Jurczak
      • Lublin, Poland, 20-081
        • Recruiting
        • Klinika Hematoonkologii i Transplantacji Szpiku
        • Contact:
          • Phone Number: +48815342397
        • Principal Investigator:
          • Waldemar Tomczak
      • Opole, Poland, 45-061
        • Recruiting
        • Szpital Wojewódzki w Opolu
        • Principal Investigator:
          • Dariusz Woszczyk
        • Contact:
          • Phone Number: +48606625611
      • Wrocław, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu Klinika Hematologii
        • Contact:
          • Phone Number: +48717842754
        • Principal Investigator:
          • Tomasz Wrobel
    • Legnica
      • Iwaszkiewicza 5, Legnica, Poland, 59-220
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny
        • Principal Investigator:
          • Jadwiga Holojda
        • Contact:
          • Phone Number: 48767211621
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Principal Investigator:
          • Monika Szarejko
        • Contact:
          • Phone Number: +48585844350
    • Poznan
      • Skorzewo, Poznan, Poland, 60 185
        • Recruiting
        • Centrum Medyczne Pratia Poznan
        • Principal Investigator:
          • Michał Kwiatek
        • Contact:
          • Phone Number: 48 793 602 210
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
          • Phone Number: +34 93 227 54 00 Ext 9214
        • Principal Investigator:
          • Julio Delgado
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Carolina Moreno Atanasio
        • Contact:
          • Phone Number: +34 93 556 5647
      • L'Hospitalet de Llobregat, Spain, 08908
        • Recruiting
        • Hospital Duran I Reynals
        • Contact:
          • Phone Number: 932607333
        • Principal Investigator:
          • EVA GONZALEZ BARCA
      • Las Palmas de Gran Canaria, Spain, 35010
        • Recruiting
        • Hospital De Gran Canaria Dr. Negrin
        • Principal Investigator:
          • Alexia Suarez Cabrera
        • Contact:
          • Phone Number: +34928450486
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Phone Number: +34619249275
        • Principal Investigator:
          • Jose A Hernandez Rivas
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Principal Investigator:
          • Javier Lopez Jimenez
        • Contact:
          • Phone Number: +34 91 3368637
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universitaria de Navarra
        • Contact:
          • Phone Number: 913531920 ext. 7511
        • Principal Investigator:
          • Rocio Figueroa Mora
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Principal Investigator:
          • Lucrecia Yáñez San Segundo
        • Contact:
          • Phone Number: 942 31 52 75
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Phone Number: +34619848594
        • Principal Investigator:
          • Alicia Rodriguez Fernandez
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Fatima De la Cruz
        • Contact:
          • Phone Number: +34955013277
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol
        • Contact:
          • Phone Number: +3493497898987
        • Principal Investigator:
          • Christelle Ferra Coll
    • Cataluna
      • Girona, Cataluna, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia de Girona (ICO Girona)
        • Contact:
          • Phone Number: +34 972 22 58 34
        • Principal Investigator:
          • Josep Maria Roncero Vidal
    • Cataluña
      • Barcelona, Cataluña, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Phone Number: +34 932746000
        • Principal Investigator:
          • Francesc Bosch Albareda
    • Madrid, Comunidad De
      • Majadahonda, Madrid, Comunidad De, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Principal Investigator:
          • Jose Antonio Garcia Marco
        • Contact:
          • Phone Number: +34 91 191 68 80
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Recruiting
        • Hospital Costa del Sol
        • Principal Investigator:
          • Angeles Medina Perez
        • Contact:
          • Phone Number: +34 (951) 976-957
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Hospital de Navarra
        • Principal Investigator:
          • Jose Maria Arguiñano Perez
        • Contact:
          • Phone Number: +34848428428
  • Taiwan
      • Changhua, Taiwan, 50544
        • Recruiting
        • Chang Bing Show Chwan Memorial Hospital
        • Principal Investigator:
          • Cheng-Shyong Chang
        • Contact:
          • Phone Number: +886-4-7813-888#70290
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: +886 6 235 3535 ext.4620
        • Principal Investigator:
          • Tsai-Yun chen
      • Taipei, Taiwan, 11259
        • Recruiting
        • Koo Foundation Sun Yan-Sen Cancer Center
        • Contact:
          • Phone Number: +886-2-28970011
        • Principal Investigator:
          • Tran-Der Tan
    • Chiayi Hsien
      • Putz, Chiayi Hsien, Taiwan, 61363
        • Recruiting
        • Chang Gung Memorial Hospital - Chiayi
        • Principal Investigator:
          • Chih-Cheng Chen
        • Contact:
          • Phone Number: +886-5-3621000 ext:2106
  • Turkey
      • Istanbul, Turkey, 34093
        • Recruiting
        • Istanbul University Istanbul Medical Faculty
        • Principal Investigator:
          • Mustafa Nuri Yenerel
        • Contact:
          • Phone Number: 31613 +902124142000
      • Istanbul, Turkey, 34457
        • Recruiting
        • Acibadem Maslak Hospital
        • Principal Investigator:
          • Mustafa Cetiner
        • Contact:
          • Phone Number: +902123146666
      • Istanbul, Turkey, 34365
        • Recruiting
        • Koc University American Hospital
        • Contact:
          • Phone Number: +902123112000
        • Principal Investigator:
          • Ahmet Burhan Ferhanoglu
      • Izmir, Turkey, 35100
        • Recruiting
        • Ege University Medical Faculty
        • Principal Investigator:
          • Filiz Vural
        • Contact:
          • Phone Number: +905325468368
      • İzmir, Turkey, 35340
        • Recruiting
        • Dokuz Eylul University Faculty of Medicine
        • Principal Investigator:
          • Faith Demirkan
        • Contact:
          • Phone Number: +905425151780
    • Ankara
      • Mamak, Ankara, Turkey
        • Recruiting
        • Ankara University Medicine Hospital
        • Principal Investigator:
          • Muhit Özcan
        • Contact:
          • Phone Number: 90 505 502 50 50
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 06560
        • Recruiting
        • Gazi University Faculty of Medicine
        • Principal Investigator:
          • Munci Yağcı
        • Contact:
          • Phone Number: +905013485659
  • United Kingdom
      • Swansea, United Kingdom, SA2 8QA
        • Recruiting
        • Singleton Hospital
        • Contact:
          • Phone Number: 01792 285301
        • Principal Investigator:
          • Unmesh Mohite
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology centre
        • Principal Investigator:
          • Sanne Lugthart
    • East Riding Of Yorkshire
      • Hull, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
        • Principal Investigator:
          • David Allsup
        • Contact:
          • Phone Number: +441482875875
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
        • Principal Investigator:
          • Rebecca Allchin
        • Contact:
          • Phone Number: +443003031573
    • London, City Of
      • London, London, City Of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Phone Number: 0203 465 6070
        • Principal Investigator:
          • John Gribben
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Recruiting
        • City Hospital, Nottingham University Hospitals
        • Contact:
          • Phone Number: 0115 9691169 ext 74725
        • Principal Investigator:
          • Nicolas Martinez-Calle
    • Tyne And Wear
      • Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
        • Recruiting
        • Sunderland Royal Hospital
        • Principal Investigator:
          • Scott Marshall
        • Contact:
          • Phone Number: 0191 5656256
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • Genesis Cancer Center
        • Contact:
          • Phone Number: 501-624-7700
        • Principal Investigator:
          • Stephen (Fred) G Divers
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Pacific Cancer Medical Center, Inc
        • Contact:
          • Phone Number: 714-999-1465
        • Principal Investigator:
          • Veena Charu
      • Berkeley, California, United States, 94705
        • Recruiting
        • Alta Bates Summit Medical Center
        • Contact:
          • Phone Number: 510-204-1591
        • Principal Investigator:
          • Oleg Krijanovski
      • Cerritos, California, United States, 90703
        • Recruiting
        • TOI Clinical Research
        • Contact:
          • Phone Number: 562-693-4477
        • Principal Investigator:
          • Richy Agajanian
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford School of Medicine-Cancer Clinical Trials Office
        • Principal Investigator:
          • Bita Fakhri
      • Rancho Mirage, California, United States, 92270
        • Recruiting
        • Eisenhower Army Medical Center
        • Contact:
          • Phone Number: 760-346-7655
        • Principal Investigator:
          • Constantin Dasanu
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Memorial Hospital
        • Principal Investigator:
          • Eliana Kozin
      • San Marcos, California, United States, 92069
        • Recruiting
        • California Cancer Associates for Research and Excellence
        • Contact:
          • Phone Number: 760-747-8935
        • Principal Investigator:
          • Edward F. McClay
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern Connecticut Hematology/Oncology Assoc.
        • Principal Investigator:
          • Dennis Slater
        • Contact:
          • Phone Number: 860-886-8362
    • Florida
      • Brooksville, Florida, United States, 34613
        • Recruiting
        • Asclepes Research Centers Florida
        • Contact:
          • Phone Number: 352-364-9401
        • Principal Investigator:
          • Daniel A Kerr
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: (239) 274-9930
        • Principal Investigator:
          • Alexander Edward Glick
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Cancer Specialists of North Florida -St Augustine
        • Contact:
          • Phone Number: 904-538-4488
        • Principal Investigator:
          • Ayed O. Ayed
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Lakeland Regional Health Systems Inc
        • Contact:
          • Phone Number: 863-904-1900
        • Principal Investigator:
          • Sushma Nakka
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: (727) 216-1143
        • Principal Investigator:
          • Jennifer Lyn Cultrera
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists East
        • Contact:
          • Phone Number: 561-366-4100
        • Principal Investigator:
          • Shachar Peles
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers
        • Principal Investigator:
          • Steven McCune
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Summit Cancer Care, P.C.
        • Contact:
          • Phone Number: 912-354-6187
        • Principal Investigator:
          • Mark Taylor
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • St Josephs-Candler Health System Inc
        • Contact:
          • Phone Number: 843-338-2405
        • Principal Investigator:
          • Gary W Thomas
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Healthcare System, Inc.
        • Principal Investigator:
          • Wangjian Zhong
        • Contact:
          • Phone Number: 502-897-1166
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Hematology Oncology Clinic
        • Contact:
          • Phone Number: 225-767-0822
        • Principal Investigator:
          • Gerald Miletello
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Cancer Center Office of Clinical Research
        • Contact:
          • Phone Number: 504-988-6234
        • Principal Investigator:
          • Nakhle Saba
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners of Maryland, PA
        • Contact:
          • Phone Number: 301-571-0019
        • Principal Investigator:
          • Bruce D Cheson
      • Ocean Pines, Maryland, United States, 21811
        • Recruiting
        • TidalHealth Richard A. Henson Cancer Institute
        • Contact:
          • Phone Number: 410-543-7032
        • Principal Investigator:
          • Justinian R Ngaiza
      • Salisbury, Maryland, United States, 21801
        • Recruiting
        • TidalHealth Peninsula Regional, Inc.
        • Contact:
          • Phone Number: 410-543-7032
        • Principal Investigator:
          • Justinian R Ngaiza
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Center
        • Principal Investigator:
          • Jay Yang
        • Contact:
          • Phone Number: 313-576-8952
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center
        • Principal Investigator:
          • Patrick Wayne Cobb
        • Contact:
          • Phone Number: (406) 238-6685
    • New York
      • Hawthorne, New York, United States, 10532
        • Recruiting
        • Westchester Medical Center
        • Principal Investigator:
          • Delong Liu
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Cancer Institute Charlotte
        • Principal Investigator:
          • Alan Skarbnik
        • Contact:
          • Phone Number: 980-302-6600
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health, Oncology Research Institute
        • Principal Investigator:
          • Alan Skarbnik
        • Contact:
          • Phone Number: 980-302-6600
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital
        • Contact:
          • Phone Number: 614-685-7377
        • Principal Investigator:
          • Jennifer A Woyach
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Asante Rogue Regional Medical Center
        • Contact:
          • Phone Number: 541-789-5003
        • Principal Investigator:
          • Aleksandra Sander
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates of York
        • Contact:
          • Phone Number: 717-741-9229
        • Principal Investigator:
          • Chanh Huynh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Lifespan Cancer Institute
        • Principal Investigator:
          • Thomas Ollila
        • Contact:
          • Phone Number: 844-222-2881
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute
        • Contact:
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Suzanne R Fanning
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Sarah Cannon Research Institute SCRI
        • Contact:
          • Phone Number: 423-622-6212
        • Principal Investigator:
          • Bertrand M Anz III
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • UTHSC Clinical Trails Unit
        • Principal Investigator:
          • Muhammad Hamid
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Recruiting
        • Brooke Army Medical Center
        • Principal Investigator:
          • Michael Osswald
        • Contact:
          • Phone Number: 210-916-0711
      • Houston, Texas, United States, 77025
        • Recruiting
        • Kelsey Research Foundation
        • Principal Investigator:
          • Sunil Patel
        • Contact:
          • Phone Number: 713-442-1700
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital Cancer Center
        • Principal Investigator:
          • Shilpan Shah
        • Contact:
          • Phone Number: 713-239-9211
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Lumi Research
        • Contact:
          • Phone Number: 832-553-3661
        • Principal Investigator:
          • Saleha S Sajid
      • Round Rock, Texas, United States, 78665
        • Recruiting
        • Baylor Scott & White Health
        • Contact:
          • Phone Number: 254-200-3200
        • Principal Investigator:
          • Ojas Vyas
    • Virginia
      • Richmond, Virginia, United States, 23228
        • Recruiting
        • Virginia Cancer Institute
        • Contact:
          • Phone Number: 804-287-3000
        • Principal Investigator:
          • Yuvraj Choudhary
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • MultiCare Health System Institute for Research and Innovation
        • Principal Investigator:
          • Brett Gourley
        • Contact:
          • Phone Number: 509-724-4440
      • Spokane, Washington, United States, 99208-1129
        • Recruiting
        • Summit Cancer Treatment Center
        • Principal Investigator:
          • Arvind Chaudhry
        • Contact:
          • Phone Number: 509-462-2273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

  • Adequate organ function

    • Platelets greater than or equal to (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
    • Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
    • Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
    • Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

  • Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
  • Known or suspected central nervous system (CNS) involvement
  • A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter
  • Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, or fungal infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
  • Ongoing inflammatory bowel disease
  • Prior exposure to BTK inhibitor (covalent or noncovalent)
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
  • Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pirtobrutinib
Administered orally.
Drug: Pirtobrutinib
Administered orally.
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Ibrutinib
Administered orally.
Drug: Ibrutinib
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR)
Time Frame: Baseline to best overall response at or before the initiation of subsequent anti-cancer therapy (if any) (approximately 3 years and 5 months)
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
Baseline to best overall response at or before the initiation of subsequent anti-cancer therapy (if any) (approximately 3 years and 5 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)
EFS by IRC per iwCLL 2018 criteria
Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)
Progression-Free Survival (PFS)
Time Frame: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
PFS by IRC per iwCLL 2018 criteria
Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
Duration of Response (DOR)
Time Frame: Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)
DOR
Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)
Overall Survival (OS)
Time Frame: Randomization to death from any cause (approximately 6 years)
OS
Randomization to death from any cause (approximately 6 years)
Time to Next Treatment (TTNT)
Time Frame: Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)
TTNT
Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)
Time to Worsening (TTW) of CLL/SLL Related Symptoms
Time Frame: Randomization to time to worsening symptoms (approximately 6 years)
Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
Randomization to time to worsening symptoms (approximately 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loxo Oncology, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Estimated)

March 24, 2028

Study Completion (Estimated)

March 24, 2029

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18281
  • J2N-OX-JZNU (Other Identifier: Eli Lilly and Company)
  • LOXO-BTK-20030 (Other Identifier: Loxo Oncology, Inc.)
  • 2021-003206-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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