Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321)

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

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.

Study Type

Interventional

Enrollment (Estimated)

500

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

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
        • Recruiting
        • Icon Cancer Care - The Wesley Medical Centre
        • Contact:
          • Phone Number: +61737374500
        • Principal Investigator:
          • Paul Eliadis
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • The St. George Hospital
        • Contact:
          • Phone Number: +61291133851
        • Principal Investigator:
          • Xavier Badoux
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
          • Phone Number: 61882045511
        • Principal Investigator:
          • Bryone Kuss
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Royal Hobart Hospital
        • Contact:
          • Phone Number: 0362228308
        • Principal Investigator:
          • Anna Johnson
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • Andrew Lowe Cancer Centre
        • Contact:
          • Phone Number: +61352267391
        • Principal Investigator:
          • Hannah Rose
    • Western Australia
      • Nedlands, Western Australia, Australia, WA6009
        • Recruiting
        • Linear Clinical Research Ltd
        • Contact:
          • Phone Number: +61893467600
        • Principal Investigator:
          • Chan Cheah
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
        • Contact:
          • Phone Number: 61892242210
        • Principal Investigator:
          • Peter Thian Guan Tan
  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen
        • Principal Investigator:
          • Olga Stiefel
        • Contact:
          • Phone Number: 43073276760
    • Osterreich
      • Salzburg, Osterreich, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg
        • Contact:
          • Phone Number: +4357255 25801
        • Principal Investigator:
          • Richard Greil
  • Belgium
      • Gent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
          • Phone Number: +32 9 332 21 32
        • Principal Investigator:
          • Fritz Offner
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
        • Contact:
          • Phone Number: 3216343821
        • Principal Investigator:
          • Vibeke Vergote
      • Roeselare, Belgium, 8800
        • Recruiting
        • AZ DELTA
        • Contact:
          • Phone Number: +3251237656
        • Principal Investigator:
          • Caressa Meert
  • Brazil
      • Rio De Janeiro, Brazil, 20231-050
        • Recruiting
        • INCA - Instituto Nacional de Cancer
        • Contact:
          • Phone Number: +55 21 99616-7963
        • Principal Investigator:
          • Ricardo de Sa Bigni
      • Rio de Janeiro, Brazil, 22061-080
        • Recruiting
        • Hospital São Lucas Copacabana
        • Contact:
          • Phone Number: +55 21 2545-4348
        • Principal Investigator:
          • Daniel Goldberg Tabak
      • Sao Paulo, Brazil, 01236-030
        • Recruiting
        • IEP - Instituto de Ensino e Pesquisas São Lucas
        • Contact:
          • Phone Number: +551136606032
        • Principal Investigator:
          • Marcelo Bellesso
      • São Paulo, Brazil, 01323-001
        • Recruiting
        • BP A Beneficencia Portuguesa da Sao Paulo
        • Contact:
          • Phone Number: +5511945205782
        • Principal Investigator:
          • Bruno Sussumu Maeda
      • São Paulo, Brazil, 1409902
        • Recruiting
        • Hospital Nove de Julho
        • Contact:
          • Phone Number: +551131479982
        • Principal Investigator:
          • Vinicius De Molla
      • São Paulo, Brazil, 01221-010
        • Recruiting
        • Irmandade Da Santa Casa de Misericordia de Sao Paulo
        • Contact:
          • Phone Number: +55 11 97109-8100
        • Principal Investigator:
          • Sergio Augusto Buzian Brasil
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center
        • Contact:
          • Phone Number: +55 11 2189-5000
        • Principal Investigator:
          • Talita Maira Bueno da Silverira da Rocha
      • São Paulo, Brazil, 05403-010
        • Recruiting
        • HC-FMUSP
        • Contact:
          • Phone Number: +55 11 4573-7543
        • Principal Investigator:
          • Juliana Pereira
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Albert Einstein Sociedade Beneficente Israelita Brasileira
        • Contact:
          • Phone Number: +55 11 99292-6463
        • Principal Investigator:
          • Guiherme Fleury Perini
    • Ceará
      • Fortaleza, Ceará, Brazil, 60115-281
        • Recruiting
        • NOHC- Nucleo de Oncologia e Hematologia do Ceara e Oncovie
        • Contact:
          • Phone Number: +55 85 99292-0767
        • Principal Investigator:
          • Jose Aurillo Rocha
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-020
        • Recruiting
        • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
        • Contact:
          • Phone Number: +556239244261
        • Principal Investigator:
          • Renato Sampaio Tavares
    • Maranhão
      • São Luís, Maranhão, Brazil, 65060-645
        • Recruiting
        • Hospital São Domingos
        • Contact:
          • Phone Number: +55 11 96187-9614
        • Principal Investigator:
          • Gilnara Fontinelle Silva Barros
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-900
        • Recruiting
        • HC-UFPR- Hospital de Clinicas da Universidade Federal do Parana
        • Contact:
          • Phone Number: +55 41 9257-8414
        • Principal Investigator:
          • Samir Nabha
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13060-904
        • Recruiting
        • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
        • Contact:
          • Phone Number: +551933438450
        • Principal Investigator:
          • Luciano Fuzzato Silva
      • Santo Andre, Sao Paulo, Brazil, 09060-870
        • Recruiting
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
        • Contact:
          • Phone Number: +551149935491
        • Principal Investigator:
          • Debora Bonito
    • São Paulo
      • São José Do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
        • Contact:
          • Phone Number: +55 17 99788-6883
        • Principal Investigator:
          • Mariana Longo Buka
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Phone Number: 7804071584
        • Principal Investigator:
          • Anthea Peters
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H6
        • Recruiting
        • BC Cancer Vancouver
        • Contact:
          • Phone Number: 6048776000
        • Principal Investigator:
          • Alina Gerrie
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Recruiting
        • CancerCare Manitoba
        • Contact:
          • Phone Number: (204) 235-3196
        • Principal Investigator:
          • Pamela Skrabek
    • Ontario
      • Toronto, Ontario, Canada, M4X 1K9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Phone Number: (416) 946-4501
        • Principal Investigator:
          • Sita Bhella
  • China
      • Chongqing, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Phone Number: +8613647633737
        • Principal Investigator:
          • Ying Xiang
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Phone Number: 13601698395
        • Principal Investigator:
          • Junning Cao
      • Tianjin, China, 300020
        • Recruiting
        • Blood Institute of the Chinese Academy of Medical science
        • Contact:
          • Phone Number: +8615900265415
        • Principal Investigator:
          • Shuhua Yi
    • Anhui
      • Hefei, Anhui, China, 233004
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Phone Number: +8618900518383
        • Principal Investigator:
          • Kaiyang Ding
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Phone Number: 861066551122
        • Principal Investigator:
          • Yujun Dong
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Phone Number: 861062017691
        • Principal Investigator:
          • Xiaoyan Ke
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Phone Number: 13439999810
        • Principal Investigator:
          • Yang Shenmiao
      • Beijing, Beijing, China, 100141
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
          • Phone Number: +8601051718492
        • Principal Investigator:
          • Zhongxia Huang
      • Haidian District, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Phone Number: +8613683398726
        • Principal Investigator:
          • Yuqin Song
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian cancer hospital
        • Contact:
          • Phone Number: +8615860091017
        • Principal Investigator:
          • Yu Yang
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Phone Number: +862087343535
        • Principal Investigator:
          • Xiaoxiao Wang
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital
        • Contact:
          • Phone Number: 020 61641888
        • Principal Investigator:
          • Ru Feng
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Cancer Center of Guangzhou Medical University
        • Contact:
          • Phone Number: +8613688896983
        • Principal Investigator:
          • Chuan Jin
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan Science and Technology University
        • Contact:
          • Phone Number: +8615137938070
        • Principal Investigator:
          • Ling Qin
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan cancer hospital
        • Contact:
          • Phone Number: 13938239725
        • Principal Investigator:
          • Kenshu Zhou
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
          • Phone Number: 862785726136
        • Principal Investigator:
          • Guohui Cui
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Central People's Hospital
        • Principal Investigator:
          • Jingming Guo
        • Contact:
          • Phone Number: +8618672907182
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Phone Number: +8673188651900
        • Principal Investigator:
          • Hui Zhou
    • Jiangsu
      • Suzhou, Jiangsu, China, 215066
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Phone Number: +8613862553199
        • Principal Investigator:
          • Zhengming Jin
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Phone Number: +8613970038386
        • Principal Investigator:
          • Fei Li
    • Jilin
      • Changchun, Jilin, China, 410013
        • Recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Cheng
        • Contact:
          • Phone Number: +8643185536383
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Phone Number: 18940251881
        • Principal Investigator:
          • Wei Yang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Phone Number: +862885422114
        • Principal Investigator:
          • Liqun Zou
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Phone Number: +861862223340123
        • Principal Investigator:
          • Huilai Zhang
    • Xinjiang
      • Urumqi, Xinjiang, China, 830002
        • Recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
          • Phone Number: +8613669926688
        • Principal Investigator:
          • Shun'e Yang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Phone Number: +8613857182590
        • Principal Investigator:
          • Haiyan Yang
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • Lishui Municipal Central Hospital
        • Contact:
          • Phone Number: +8618368406114
        • Principal Investigator:
          • Linjie Li
  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • Fakultni Nemocnice Brno
        • Contact:
          • Phone Number: +420532233642
        • Principal Investigator:
          • Jiri Mayer
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Contact:
          • Phone Number: +420495832159
        • Principal Investigator:
          • David Belada
  • Denmark
      • Odense, Denmark, DK-5000
        • Recruiting
        • Odense Universitetshospital
        • Contact:
          • Phone Number: +4551640958
        • Principal Investigator:
          • Jacob Haaber Christensen
    • Jutland
      • Aarhus N, Jutland, Denmark, DK-8200
        • Recruiting
        • Aarhus Universitetshospital, Aarhus Sygehus
        • Contact:
          • Phone Number: +4521391053
        • Principal Investigator:
          • Bentzen Hans Herluf Nørregaard
  • France
      • Lille cedex, France, 59020
        • Recruiting
        • Hôpital Saint Vincent de Paul
        • Contact:
          • Phone Number: +33320874532
        • Principal Investigator:
          • Amorim Sandy
      • Nantes Cedex 1, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Contact:
          • Phone Number: 02 40 08 32 71
        • Principal Investigator:
          • Thomas Gastinne
      • Paris, France, 75013
        • Recruiting
        • Groupe Hospitalier Pitie-Salpetriere
        • Contact:
          • Phone Number: +33142162330
        • Principal Investigator:
          • Veronique Morel-Malek
      • Pessac Cedex, France, 33600
        • Recruiting
        • Centre hospitalier universitaire de Haut Leveque
        • Contact:
          • Phone Number: +33557656511
        • Principal Investigator:
          • Kamal Bouabdallah
      • Pierre Benite Cedex, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • Phone Number: +33478864307
        • Principal Investigator:
          • Violaine Safar
      • Politiers, France, 86021
        • Recruiting
        • Pole Regionalde Cancérologie(CHU de Poitiers)
        • Contact:
          • Phone Number: +33549444472
        • Principal Investigator:
          • Vincent Delwail
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Chu De Nancy Hop D'Adultes De Brabois
        • Contact:
          • Phone Number: +33383153257
        • Principal Investigator:
          • Pierre Feugier
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
        • Contact:
          • Phone Number: 33556333244
        • Principal Investigator:
          • Fontanet Bijou
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Recruiting
        • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
        • Contact:
          • Phone Number: +33232082223
        • Principal Investigator:
          • Herve Tilly
    • Tours Cedex 9
      • Tours, Tours Cedex 9, France, 37044
        • Recruiting
        • CHRU de Tours
        • Contact:
          • Phone Number: +33247473712
        • Principal Investigator:
          • Caroline Dartigeas
    • Île-de-France
      • Saint-Cloud, Île-de-France, France, 92210
        • Recruiting
        • Institut Curie
        • Contact:
          • Phone Number: +33 1 47 11 15 15
        • Principal Investigator:
          • Carole Soussain
  • Germany
      • Hamburg, Germany, 22081
        • Recruiting
        • OncoResearch Lerchenfeld GmbH
        • Contact:
          • Phone Number: +49402260465052
        • Principal Investigator:
          • Thomas Wolff
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin Johannes Gutenberg Universität Mainz
        • Principal Investigator:
          • Georg Hess
        • Contact:
          • Phone Number: +496131175040
      • Munster, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster
        • Contact:
          • Phone Number: +49251-83-44567
        • Principal Investigator:
          • Andrea Kerkhoff
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Recruiting
        • Universitatsklinikum Ulm
        • Contact:
          • Phone Number: +4973150056000
        • Principal Investigator:
          • Stephan Stilgenbauer
    • Bayern
      • München, Bayern, Germany, 81377
        • Recruiting
        • Klinikum der Universität München Großhadern
        • Contact:
          • Phone Number: +498970950
        • Principal Investigator:
          • Martin Dreyling
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster
        • Contact:
          • Phone Number: +49251-83-44567
        • Principal Investigator:
          • Andrea Kerkhoff
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 65068
        • Recruiting
        • InVO - Institut für Versorgungsforschung in der Onkologie GbR
        • Contact:
          • Phone Number: +49 261 921 5693 20
        • Principal Investigator:
          • Rudolf Weide
    • Schleswig Holstein
      • Kiel, Schleswig Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
        • Contact:
          • Phone Number: +4943116974219
        • Principal Investigator:
          • Christiane Pott
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem
        • Principal Investigator:
          • Árpád Illes
        • Contact:
          • Phone Number: +3652255196
    • Baranya
      • Pécs, Baranya, Hungary, 7632
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Központ
        • Contact:
          • Phone Number: '+36305424314
        • Principal Investigator:
          • Hussain Hussain Alizadeh
  • Ireland
    • Dublin 8
      • Dublin, Dublin 8, Ireland, D08 NHY1
        • Recruiting
        • St James's Hosptial
        • Contact:
          • Phone Number: 00353 1410 3546
        • Principal Investigator:
          • Elisabeth Vandenberghe
  • Israel
      • Haifa, Israel, 3339419
        • Recruiting
        • Bnai Zion Medical Center
        • Contact:
          • Phone Number: +972506268114
        • Principal Investigator:
          • Tamar Tadmor
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Phone Number: +972508946168
        • Principal Investigator:
          • David Lavie
      • Ramat Gan, Israel
        • Recruiting
        • Chaim Sheba Medical Center
        • Contact:
          • Phone Number: +97239377906
        • Principal Investigator:
          • Irena Amitai
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
          • Phone Number: +97236973782
        • Principal Investigator:
          • Yair Herishanu
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS - AOU di Bologna
        • Contact:
          • Phone Number: +39 051 214 4082
        • Principal Investigator:
          • Pier Luigi Zinzani
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Phone Number: +39103358978
        • Principal Investigator:
          • Roberto Lemoli
      • Messina, Italy, 98158
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
        • Contact:
          • Phone Number: +39903992246
        • Principal Investigator:
          • Donato Mannina
      • Palermo, Italy, 90100
        • Recruiting
        • Ospedale Vincenzo Cervello
        • Contact:
          • Phone Number: +390916884002
        • Principal Investigator:
          • Caterina Patti
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Principal Investigator:
          • Sara Galimberti
        • Contact:
          • Phone Number: +3950993488
      • Ravenna, Italy, 48020
        • Recruiting
        • Ospedale Santa Maria delle Croci
        • Contact:
          • Phone Number: +390544286223
        • Principal Investigator:
          • Monica Tani
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale Santa Maria Nuova
        • Contact:
          • Phone Number: +390522296623
        • Principal Investigator:
          • Fiorella Ilariucci
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale di Circolo e Fondazione Macchi Varese
        • Principal Investigator:
          • Michele Merli
        • Contact:
          • Phone Number: +39332278848
    • AL
      • Alessandria, AL, Italy, 15100
        • Recruiting
        • Presidio Ospedaliero Civile Santi Antonio e Biagio
        • Contact:
          • Phone Number: +390131206440
        • Principal Investigator:
          • Francesco Zallio
    • Ancona
      • Torrette, Ancona, Italy, 60020
        • Recruiting
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
        • Principal Investigator:
          • Attilio Olivieri
        • Contact:
          • Phone Number: +39715964235
    • Bari
      • Viale Orazio Flacco, Bari, Italy, 70124
        • Recruiting
        • Irccs Istituto Tumori Giovanni Paolo Ii
        • Principal Investigator:
          • Attilio Guarini
        • Contact:
          • Phone Number: +39805555224
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
        • Contact:
          • Phone Number: +39543739100
        • Principal Investigator:
          • Gerardo Musuraca
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Phone Number: +390226437649
        • Principal Investigator:
          • Andrès Ferreri
    • Potenza
      • Rionero in Vulture, Potenza, Italy, 85028
        • Recruiting
        • Irccs Crob
        • Contact:
          • Phone Number: +39972726685
        • Principal Investigator:
          • Giuseppe Pietrantuono
  • Japan
      • Hiroshima, Japan, 720-0001
        • Recruiting
        • Chugoku Central Hospital
        • Contact:
          • Phone Number: +81849702121
        • Principal Investigator:
          • Taiga Kuroi
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
        • Contact:
          • Phone Number: +81963442111
        • Principal Investigator:
          • Hiro Tatetsu
      • Kyoto-shi, Japan, 602 8566
        • Recruiting
        • Kyoto Furitsu Medical University Hospital
        • Contact:
          • Phone Number: +81752515111
        • Principal Investigator:
          • Junya Kuroda
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
          • Phone Number: +81862237151
        • Principal Investigator:
          • Daisuke Ennishi
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Recruiting
        • Nagoya Medical Center
        • Contact:
          • Phone Number: +81529511111
        • Principal Investigator:
          • Hirokazu Nagai
      • Nagoya, Aichi, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
          • Phone Number: +81528515511
        • Principal Investigator:
          • Shigeru Kusumoto
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
          • Phone Number: +81117161161
        • Principal Investigator:
          • Daigo Hashimoto
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital
        • Contact:
          • Phone Number: +81-78-302-4321
        • Principal Investigator:
          • Ryusuke Yamamoto
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Recruiting
        • Kochi Medical School Hospital
        • Contact:
          • Phone Number: +81952316511
        • Principal Investigator:
          • Kensuke Kojima
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
          • Phone Number: +81227177165
        • Principal Investigator:
          • Noriko Fukuhara
    • Osaka
      • Osaka Sayama-shi, Osaka, Japan, 589 8511
        • Recruiting
        • Kindai University Hospital
        • Contact:
          • Phone Number: +81723660221
        • Principal Investigator:
          • Takahiro Kumode
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Recruiting
        • Saitama Medical Center
        • Contact:
          • Phone Number: +81492283400
        • Principal Investigator:
          • Masahiro Kizaki
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
          • Phone Number: +81335200111
        • Principal Investigator:
          • Dai Maruyama
      • Shinagawa-KU, Tokyo, Japan, 141-8625
        • Recruiting
        • NTT Medical Center Tokyo
        • Contact:
          • Phone Number: +81334486111
        • Principal Investigator:
          • Kensuke Usuki
  • 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
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Hospital
        • Contact:
          • Phone Number: +82324602858
        • Principal Investigator:
          • JAE-HOON LEE
    • Seogu
      • Busan, Seogu, Korea, Republic of, 49267
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
          • Phone Number: +82519905820
        • Principal Investigator:
          • Ho Sup Lee
    • Seoul
      • Seocho-Gu, Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea-Seoul St. Mary's Hospital
        • Contact:
          • Phone Number: +82222286056
        • Principal Investigator:
          • Ki-Seong Eom
    • Seoul, Korea
      • Seoul, Seoul, Korea, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Phone Number: +821091175012
        • Principal Investigator:
          • Youngil Koh
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Phone Number: +82222281972
        • Principal Investigator:
          • Jin Seok Kim
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Phone Number: +82230105940
        • Principal Investigator:
          • Dok Hyun Yoon
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Phone Number: +82234106548
        • Principal Investigator:
          • Won Seog Kim
  • Netherlands
      • Den Haag, Netherlands, 2545 AA
        • Recruiting
        • Ziekenhuisapotheek HagaZiekenhuis
        • Contact:
          • Phone Number: +317003592000
        • Principal Investigator:
          • Lara Bohmer
      • Roosendaal, Netherlands, 4708 AE
        • Recruiting
        • Bravis Ziekenhuis
        • Contact:
          • Phone Number: +31887066820
        • Principal Investigator:
          • Nicole de Graauw
      • Rotterdam, Netherlands, 3015 AA
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Phone Number: +31107041367
        • Principal Investigator:
          • Jeannette Doorduijn
      • TM Hoofddorp, Netherlands, 2134
        • Recruiting
        • Spaarne Gasthuis
        • Contact:
          • Phone Number: +31238907171
        • Principal Investigator:
          • Aart Beeker
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Christchurch Hospital
        • Contact:
          • Phone Number: +6433640377
        • Principal Investigator:
          • Peter Ganly
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Recruiting
        • Middlemore Clinical Trials
        • Contact:
          • Phone Number: +64021955207
        • Principal Investigator:
          • Rajeeve Rajagopal
  • Poland
      • Krakow, Poland, 30-510
        • Recruiting
        • Pratia MCM Krakow
        • Contact:
          • Phone Number: +48602338290
        • Principal Investigator:
          • Wojciech Jurczak
      • Skórzewo, Poland, 60-185
        • Recruiting
        • Centrum Medyczne Pratia Poznań
        • Principal Investigator:
          • Michał Kwiatek
        • Contact:
          • Phone Number: 48793602210
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
        • Contact:
          • Phone Number: +48785050296
        • Principal Investigator:
          • Tomasz Wrobel
      • Łódź, Poland, 93510
        • Recruiting
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
        • Principal Investigator:
          • Tadeusz Robak
        • Contact:
          • Phone Number: +48602272952
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-081
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej
        • Contact:
          • Phone Number: +48814541226
        • Principal Investigator:
          • Krzysztof Giannopoulos
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Contact:
          • Phone Number: +48583492230
        • Principal Investigator:
          • Magdalena Dutka
  • Portugal
      • Lisboa, Portugal, 1099-035
        • Recruiting
        • IPOFG - Lisboa
        • Contact:
          • Phone Number: +351217200441
        • Principal Investigator:
          • Filipa Moita
      • Lisboa, Portugal, 1400-038
        • Recruiting
        • Champalimaud Foundation
        • Contact:
          • Phone Number: +351210480200
        • Principal Investigator:
          • Cristina Joao
  • Russian Federation
      • Moscow, Russian Federation, 125101
        • Recruiting
        • GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin
        • Contact:
          • Phone Number: +74997288488
        • Principal Investigator:
          • Vladimir Vorobyev
      • Saint Petersburg, Russian Federation, 191024
        • Recruiting
        • Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
        • Contact:
          • Phone Number: +79213708846
        • Principal Investigator:
          • Aleksei Kuvshinov
      • Saint-Petersburg, Russian Federation, 197022
        • Recruiting
        • State Medical University named after I.P. Pavlov
        • Contact:
          • Phone Number: +78129096209
        • Principal Investigator:
          • Natalia Mikhailova
    • Omskaya Oblast'
      • Omsk, Omskaya Oblast', Russian Federation, 644013
        • Recruiting
        • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
        • Contact:
          • Phone Number: +79136882778
        • Principal Investigator:
          • Mikhail V. Dvorkin
  • Spain
      • A Coruña, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago
        • Principal Investigator:
          • Adrian Mosquera Orgueira
        • Contact:
          • Phone Number: +3495054993
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Phone Number: +34 932746000
        • Principal Investigator:
          • Francesc Bosch Albareda
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Phone Number: +34932275400 Ext 4353
        • Principal Investigator:
          • Eva Soca
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Phone Number: +34913908678
        • Principal Investigator:
          • Ana Jimenez Ubieto
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
          • Phone Number: +34915868394
        • Principal Investigator:
          • Mariana Bastos Oreiro
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Phone Number: +34915504800-2218
        • Principal Investigator:
          • Raul Córdoba Mascuñano
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Infanta Leonor
        • Contact:
          • Phone Number: +34911918932
        • Principal Investigator:
          • Jose Angel Hernandes Rivas
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Phone Number: +34913908282
        • Principal Investigator:
          • Carlos Grande Garcia
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Phone Number: +3495054993
        • Principal Investigator:
          • Isabel Maria Fernandez Roman
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario de Valencia
        • Contact:
          • Phone Number: +34 619 943 699
        • Principal Investigator:
          • Alfonso Algarra
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Phone Number: 951032508
        • Principal Investigator:
          • Antonio Rueda Dominguez
    • Barcelona
      • Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Hospital Duran I Reynals
        • Contact:
          • Phone Number: +34932607733
        • Principal Investigator:
          • EVA GONZALEZ BARCA
  • Switzerland
      • Bellinzona, Switzerland, CH-6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli
        • Contact:
          • Phone Number: +41918118931
        • Principal Investigator:
          • Anastasios Stathis
    • Luzern
      • Luzern 16, Luzern, Switzerland, 6000
        • Recruiting
        • Kantonsspital Luzern
        • Contact:
          • Phone Number: +41412055876
        • Principal Investigator:
          • Thilo Zander
  • Taiwan
      • Chiayi County, Taiwan, 61363
        • Recruiting
        • Chang Gung Memorial Hospital - Chiayi
        • Contact:
          • Phone Number: +8865362100 2106
        • Principal Investigator:
          • Chih-Cheng Chen
      • Kaohsiung, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Phone Number: +88673121101-6110
        • Principal Investigator:
          • Hui-Hui Hsiao
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Phone Number: 5050 +886422052121
        • Principal Investigator:
          • Su-Peng Yeh
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Phone Number: +886623535354620
        • Principal Investigator:
          • Tsai-Yun chen
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Phone Number: 66259 +886223133456
        • Principal Investigator:
          • Tai-Chung Huang
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Phone Number: 8904 +886228712121
        • Principal Investigator:
          • Jyh-Pyng Gau
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou
        • Contact:
          • Phone Number: +88633281200 2524
        • Principal Investigator:
          • Hsuan-Jen Shih
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
          • Phone Number: 1714 +886287923311
        • Principal Investigator:
          • Yeu-Chin Chen
  • United Kingdom
      • Newmarket, United Kingdom, CB8 7XN
        • Recruiting
        • GenesisCare Cambridge
        • Contact:
          • Phone Number: +441223245151
        • Principal Investigator:
          • George Follows
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • City Hospital, Nottingham University Hospitals
        • Contact:
          • Phone Number: +441159691169
        • Principal Investigator:
          • Mark Bishton
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • Phone Number: +441752432595
        • Principal Investigator:
          • David Lewis
      • Windsor, United Kingdom, SL4 3HD
        • Recruiting
        • GenesisCare, Windsor
        • Contact:
          • Phone Number: 0175341-8444
        • Principal Investigator:
          • Jaimal Kothari
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • New Cross Hospital
        • Contact:
          • Phone Number: +441902695271
        • Principal Investigator:
          • Abraham Jacob
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary
        • Contact:
          • Phone Number: +443454566000
        • Principal Investigator:
          • Gavin Preston
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Phone Number: +4407728268414
        • Principal Investigator:
          • Toby Eyre
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G12OYN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
        • Contact:
          • Phone Number: +441413017000
        • Principal Investigator:
          • Pamela McKay
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
          • Phone Number: +442086613582
        • Principal Investigator:
          • Ian Chau
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology & Hematology, LLC
        • Principal Investigator:
          • Steven Liu
        • Contact:
          • Phone Number: 907-257-9851
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Oncology Associates, P.C. - HOPE
        • Contact:
          • Phone Number: 602-277-4868
        • Principal Investigator:
          • Michael S Roberts
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • Arizona Oncology Associates, P.C. - HOPE
        • Principal Investigator:
          • Sudhir Manda
        • Contact:
          • Phone Number: 520-886-0206
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • St. Joseph Heritage Healthcare
        • Contact:
          • Phone Number: 714-446-5804
        • Principal Investigator:
          • Steven Kim
      • Long Beach, California, United States, 90805
        • Recruiting
        • The Oncology Institute of Hope and Innovation
        • Contact:
          • Phone Number: 562-693-4477
        • Principal Investigator:
          • Omkar S Marathe
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Medical Center
        • Contact:
          • Phone Number: 310-582-4070
        • Principal Investigator:
          • Monica Mead
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Center
        • Contact:
          • Phone Number: 303-385-2000
        • Principal Investigator:
          • David J Andorsky
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants, PA
        • Contact:
          • Phone Number: 302-366-1200
        • Principal Investigator:
          • Jamal Misleh
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 239-274-9930
        • Principal Investigator:
          • Vance M. Wright-Browne
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Han Tun
        • Contact:
          • Phone Number: 904-953-2000
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 727-216-1143
        • Principal Investigator:
          • Gustavo Adolfo Fonseca
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 850-877-8166
        • Principal Investigator:
          • Viralkumar Bhanderi
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Oncology-Hematology Associates of West Broward
        • Principal Investigator:
          • Sumit Sawhney
        • Contact:
          • Phone Number: 954-726-0035
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists East
        • Contact:
          • Phone Number: 561-366-4100
        • Principal Investigator:
          • Shachar Peles
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • University of Kentucky Markey Cancer Center
        • Contact:
          • Phone Number: 859-257-4500
        • Principal Investigator:
          • Reinhold Munker
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • Mercy Health-Paducah Medical Oncology and Hematology
        • Contact:
          • Phone Number: 270-441-4343
        • Principal Investigator:
          • Wederson M Claudino
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Hematology Oncology Clinic
        • Contact:
          • Phone Number: 2257670822260
        • Principal Investigator:
          • Michael J. Castine
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Cancer Center Office of Clinical Research
        • Contact:
          • Phone Number: 504-988-6300
        • Principal Investigator:
          • Nakhle Saba
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Greenebaum Comprehensive Cancer Center
        • Contact:
          • Phone Number: 410-328-7904
        • Principal Investigator:
          • Seung T Lee
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Phone Number: 617-582-9555
        • Principal Investigator:
          • Inhye Ahn
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Phone Number: 734-764-1817
        • Principal Investigator:
          • Tycel J Phillips
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
          • Phone Number: 313-576-9750
        • Principal Investigator:
          • Dahlia Sano
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Yucai Wang
        • Contact:
          • Phone Number: 507-284-2511
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
        • Contact:
          • Phone Number: 816861470057665
        • Principal Investigator:
          • Suman Kambhampati
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Medical School
        • Contact:
          • Phone Number: 314-747-7222
        • Principal Investigator:
          • Brad S. Kahl
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Phone Number: 402-559-5255
        • Principal Investigator:
          • Julie Vose
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
          • Phone Number: 702-952-3400
        • Principal Investigator:
          • Edwin Kingsley
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Hematology Oncology Associates of Northern New Jersey
        • Principal Investigator:
          • Charles M Farber
        • Contact:
          • Phone Number: 973-971-7960
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Phone Number: 212-639-2668
        • Principal Investigator:
          • Anita J Kumar
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
          • Phone Number: 212-305-5098
        • Principal Investigator:
          • Andrew H Lipsky
      • New York, New York, United States, 10532
        • Recruiting
        • New York Medical College
        • Principal Investigator:
          • Delong Liu
        • Contact:
          • Phone Number: 914-493-7514
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Recruiting
        • Messino Cancer Center
        • Contact:
          • Phone Number: 828-212-7021
        • Principal Investigator:
          • Christopher H Chay
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
          • Phone Number: 980-442-3105
        • Principal Investigator:
          • Ryan W Jacobs
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University School of Medicine
        • Principal Investigator:
          • Mary Beth Seegars
        • Contact:
          • Phone Number: 336-716-7972
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care Inc
        • Contact:
          • Phone Number: 513-686-5270
        • Principal Investigator:
          • Miguel Islas-Ohlmayer
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute & Research Ctr.
        • Contact:
          • Phone Number: 5416835001
        • Principal Investigator:
          • Jeff Porter Sharman
      • Salem, Oregon, United States, 97301
        • Recruiting
        • Oregon Oncology Specialists
        • Contact:
          • Phone Number: 503-561-6444
        • Principal Investigator:
          • Janelle Meyer
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
          • Phone Number: 412-235-1020
        • Principal Investigator:
          • Jing-Zhou Hou
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute SCRI
        • Contact:
          • Phone Number: 615-524-4074
        • Principal Investigator:
          • Ian Flinn
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology-Austin Midtown
        • Contact:
          • Phone Number: 512-421-4100
        • Principal Investigator:
          • Jason M Melear
      • Bedford, Texas, United States, 76022
        • Recruiting
        • Texas Oncology - Bedford
        • Contact:
          • Phone Number: 817-251-9080
        • Principal Investigator:
          • Henrik Bo Illum
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Phone Number: 713-792-2860
        • Principal Investigator:
          • Luhua Wang
      • Houston, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Bayler Charles A. Sammons Cancer Center
        • Contact:
          • Phone Number: 214-370-1763
        • Principal Investigator:
          • Moshe Levy
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology - McAllen
        • Principal Investigator:
          • Guillermo Lazo-Diaz
        • Contact:
          • Phone Number: 956-687-5150
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Oncology - McKinney
        • Contact:
          • Phone Number: 972-867-3577
        • Principal Investigator:
          • Monte F Jones
      • Sherman, Texas, United States, 75090
        • Recruiting
        • Texas Oncology - Sherman
        • Contact:
          • Phone Number: 903-892-9455
        • Principal Investigator:
          • Tammy E Roque
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Tyler
        • Principal Investigator:
          • Habte A Yimer
        • Contact:
          • Phone Number: 903-579-9800
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
          • Phone Number: 801-585-0255
        • Principal Investigator:
          • Harsh Shah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
          • Phone Number: 434-243-2649
        • Principal Investigator:
          • Craig Anthony Portell
      • Gainesville, Virginia, United States, 20155
        • Recruiting
        • Virginia Cancer Specialists, PC
        • Principal Investigator:
          • Mitul Gandhi
        • Contact:
          • Phone Number: 703-280-5390
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance
        • Contact:
          • Phone Number: 206-606-7031
        • Principal Investigator:
          • Stephen Smith
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
          • Phone Number: 608-287-2304
        • Principal Investigator:
          • Saurabh Rajguru
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Memorial Lutheran Hospital
        • Contact:
          • Phone Number: 414-805-4617
        • Principal Investigator:
          • Nirav Shah

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 MCL diagnosis
  • Previously treated with at least one prior line of systemic therapy for MCL
  • Measurable disease per Lugano criteria
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
  • Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
  • Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
  • AST and ALT ≤ 3.0 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN.
  • Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

Exclusion Criteria:

  • Prior treatment with an approved or investigational BTK inhibitor
  • History of bleeding diathesis
  • History of stroke or intracranial hemorrhage within 6 months of randomization
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
  • Clinically significant cardiovascular disease
  • Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs
  • Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
  • Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Vaccination with live vaccine within 28 days prior to randomization

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: Arm A (Pirtobrutinib)
Orally
Drug: Pirtobrutinib
Oral
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)
Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.
Drug: Acalabrutinib
Oral
Other Names:
  • Calquence
Drug: Ibrutinib
Oral
Other Names:
  • Imbruvica
Drug: Zanubrutinib
Oral
Other Names:
  • Brukinsa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
Time Frame: Up to approximately 24 months
Assessed per Lugano criteria
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Defined as the time from randomization to progressive disease (PD) or start of new treatment for MCL or withdrawal from trial due to toxicity or death
Up to approximately 24 months
To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Time from randomization to time when discontinuation criteria met
Up to approximately 24 months
Time to worsening (TTW) of MCL-related symptoms
Time Frame: Up to approximately 24 months
Using symptom questions identified from the European Organization for Research and Treatment of Cancer (EORTC) item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
Up to approximately 24 months
Comparative Tolerability as measured by proportion of time with high side effect burden
Time Frame: Up to approximately 24 months
Using 18 items covering 10 Patient Reported Outcome- Common Terminology Criteria for Adverse Events (PRO-CTCAE) concepts for frequency (0-5 with 5 as most frequent), and/or presence (0-1 with 1 being present), or Severity (0-5 with 5 as most severe) and/or presence (0-1 with 1 being present); these selective adverse events will be framed and then overall side effect burden will be ascertained with the Functional Assessment of Cancer Therapy (FACT) - Item GP5. The range of this item is 0 -4 with 4 as most bothersome.
Up to approximately 24 months
To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Assessed per Lugano criteria
Up to approximately 24 months
To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Assessed per Lugano criteria
Up to approximately 24 months
To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time Frame: Up to approximately 24 months
Assessed by survival
Up to approximately 24 months

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: Patient Advocacy, Loxo Oncology, Inc.

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.

General Publications

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)

April 8, 2021

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

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

  • LOXO-BTK-20019
  • J2N-OX-JZNM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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