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NCT06973187RecruitingPhase 3

A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
500 (estimated)
First submitted
7 May 2025
Start date
4 Sept 2025
Primary completion date
17 Apr 2028
Lead sponsor
BeOne Medicines
NCT number
NCT06973187
EU CT number
2025-522860-34-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 500
  • From 4 Sept 2025 to the primary completion date, 17 Apr 2028
  • 217 sites in 24 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).

Other illness

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
  • History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
  • Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
  • Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (217)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
FUNDALEU
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CABAArgentinaRecruiting
Sanatorio Allende
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CórdobaArgentinaRecruiting
Centro Oncologico de Integracion Regional (Coir)
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MendozaArgentinaRecruiting
Hospital Privado de Rosario
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RosarioArgentinaRecruiting
Medical University of Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Flinders Medical Centre
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Bedford PKAustraliaRecruiting
Pindara Private Hospital
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BenowaAustraliaRecruiting
Sunshine Coast Hospital and Health Service
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BirtinyaAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
St Vincents Hospital Melbourne
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FitzroyAustraliaRecruiting
Peninsula Private Hospital
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FrankstonAustraliaRecruiting
Austin Health
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HeidelbergAustraliaRecruiting
St George Private Hospital
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KogarahAustraliaRecruiting
Cabrini Hospital - Malvern
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MalvernAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
Linear Clinical Research
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NedlandsAustraliaRecruiting
John Flynn Private Hospital
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TugunAustraliaRecruiting
Westmead Private Hospital
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WestmeadAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
UZ Gent
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GentBelgiumRecruiting
AZ Groeninge
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KortrijkBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Emmaues
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MechelenBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumRecruiting
Centro de Pesquisa Clinica Dom Bosco Ltda
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AraçatubaBrazilRecruiting
Hospital Felicio Rocho
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Belo HorizonteBrazilRecruiting
ICTR - Instituto do Câncer e Transplante de Curitiba
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CuritibaBrazilRecruiting
Hospital de Clinicas de Goiania Ufg
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GoiâniaBrazilRecruiting
INCA - Instituto Nacional de Câncer
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Rio de JaneiroBrazilRecruiting
Ensino e Terapia de Inovação Clínica AMO - ETICA
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SalvadorBrazilRecruiting
Hospital Nove de Julho - dasa
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São PauloBrazilRecruiting
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
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São PauloBrazilRecruiting
Inselspital Bern (Inselspital, Universitatsspital Bern)
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BernSwitzerlandRecruiting
Universitätsspital Zürich
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ZurichSwitzerlandRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Binzhou Medical University Hospital
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BinzhouChinaRecruiting
The First Hospital of Jilin University
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ChangchunChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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ChengduChinaRecruiting
The Second Hospital of Dalian Medical University
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DalianChinaRecruiting
Dazhou Central Hospital
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DazhouChinaRecruiting
Fujian Medical University Union Hospital
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FuzhouChinaRecruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaRecruiting
Guizhou Provincial Peoples Hospital
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GuiyangChinaRecruiting
The First Affiliated Hospital of Harbin Medical University
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HarbinChinaRecruiting
Jiangmen Central Hospital
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JiangmenChinaRecruiting
First Affiliated Hospital of Kunming Medical University
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KunmingChinaRecruiting
The First Hospital of Lanzhou University
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LanzhouChinaRecruiting
The Affiliated Hospital of Southwest Medical University
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LuzhouChinaRecruiting
The Second Affiliated Hospital of Nanchang University
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NanchangChinaRecruiting
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Affiliated Hospital of Nantong University
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NantongChinaRecruiting
The First Affiliated Hospital of Ningbo University
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NingboChinaRecruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Shengjing Hospital Of China Medical University
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ShenyangChinaRecruiting
The Fourth Hospital of Hebei Medical University East Branch
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ShijiazhuangChinaRecruiting
The First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Taian City Central Hospital
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TaianChinaRecruiting
Shanxi Bethune Hospital
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TaiyuanChinaRecruiting
Institute of Hematology and Hospital of Blood Disease
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TianjinChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technologychegu Branch
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WuhanChinaRecruiting
Wuxi Peoples Hospital
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WuxiChinaRecruiting
The Second Affiliated Hospital of XiAn Jiaotong University
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Xi'anChinaRecruiting
Qinghai university affiliated hospital
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XiningChinaRecruiting
Xuchang Central Hospitalluminghu Branch
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XuchangChinaRecruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH
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DortmundGermanyRecruiting
Staedtisches Klinikum Karlsruhe gGmbH
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KarlsruheGermanyRecruiting
MVZ für Hämatologie und Onkologie Lübeck GmbH
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LübeckGermanyRecruiting
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
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StuttgartGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Medizinische Studiengesellschaft NORD-WEST GmbH
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WesterstedeGermanyRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Universitario De Burgos
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BurgosSpainRecruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Centre Henri Becquerel
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RouenFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
CHRU De Nancy
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Vandoeuvre Les Nancy CedexFranceRecruiting
University Hospitals Sussex NHS Foundation Trust
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BrightonUnited KingdomRecruiting
Kent and Canterbury Hospital
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CanterburyUnited KingdomRecruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
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NorwichUnited KingdomRecruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomRecruiting
Spire Leeds Healthcare Spire Leeds Hospital
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RoundhayUnited KingdomRecruiting
Salisbury Foundation Trust
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SalisburyUnited KingdomRecruiting
Bnai Zion Medical Center
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HaifaIsraelRecruiting
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Meir Medical Center
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KfarSavaIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Sourasky Tel Aviv Medical Center
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Tel AvivIsraelRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Tokyo Metropolitan Komagome Hospital
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BunkyokuJapanRecruiting
Fukushima Medical University Hospital
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FukushimaJapanRecruiting
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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HiroshimaJapanRecruiting
Dokkyo Medical University Saitama Medical Center
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KoshigayaJapanRecruiting
Cancer Institute Hospital of JFCR
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KōtokuJapanRecruiting
Kumamoto University Hospital
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KumamotoJapanRecruiting
Japanese Red Cross Kyoto Daini Hospital
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KyotoshiJapanRecruiting
Matsuyama Red Cross Hospital
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MatsuyamaJapanRecruiting
Aichi Cancer Center Hospital Clinical Oncology
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NagoyaJapanRecruiting
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
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NakamurakuJapanRecruiting
Kochi Medical School Hospital
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NankokuJapanRecruiting
Oita Prefectural Hospital
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ŌitaJapanRecruiting
Okayama University Hospital
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OkayamaJapanRecruiting
Osaka Metropolitan University Hospital
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OsakaJapanRecruiting
Kindai University Hospital
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SakaiJapanRecruiting
Aiiku Hospital
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SapporoJapanRecruiting
National Hospital Organization (Nho) Disaster Medical Center
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TachikawashiJapanRecruiting
Yamagata University Hospital
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YamagataJapanRecruiting
Gyeongsang National University Hospital
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JinjuSouth KoreaRecruiting
The Catholic University of Korea, Seoul St Marys Hospital
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SeochoGuSouth KoreaRecruiting
Severance Hospital Yonsei University Health System
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SeodaemunGuSouth KoreaRecruiting
Pusan National University Hospital
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SeoguSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Centro de Investigacion Clinica Gramel
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MéxicoMexicoRecruiting
Christus Latam Hub Center of Excellence and Innovation Sc
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MonterreyMexicoRecruiting
Centro de Investigacion Clinica de Oaxaca
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Oaxaca CityMexicoRecruiting
Centro Hemato Oncologico Privado de Toluca
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TolucaMexicoRecruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsRecruiting
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsRecruiting
Groene Hart Ziekenhuis
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GoudaNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
North Shore Hospital
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AucklandNew ZealandRecruiting
Tauranga Hospital
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TaurangaNew ZealandRecruiting
Wellington Regional Hospital (Ccdhb)
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WellingtonNew ZealandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandRecruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandRecruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
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TorunPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Auxilio Mutuo Cancer Center
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San JuanPuerto RicoRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GothenburgSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Tan Tock Seng Hospital Haematology
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SingaporeSingaporeRecruiting
Singapore General Hospital
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SingaporeSingaporeRecruiting
Mary Bird Perkins Cancer Center
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Baton RougeUnited StatesRecruiting
Our Lady of the Lake Hospital
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Baton RougeUnited StatesRecruiting
University of Alabama At Birmingham Hospital
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BirminghamUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Atrium Health Levine Cancer Institute (Lci)
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CharlotteUnited StatesRecruiting
University of Chicago Medical Center
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ChicagoUnited StatesRecruiting
Dayton Physician Network
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DaytonUnited StatesRecruiting
Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Titan Health Partners Llc Dba Astera Cancer Care
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East BrunswickUnited StatesRecruiting
John Theurer Cancer Center, Hackensack University Medical Center
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HackensackUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Kaiser Permanente Southern California
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IrvineUnited StatesRecruiting
Cancer Specialists of North Florida
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JacksonvilleUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
Gunderson Health System
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La CrosseUnited StatesRecruiting
University of California, San Diego (UCSD) - Moores Cancer Center
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La JollaUnited StatesRecruiting
Cancer and Blood Specialty Clinic
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Los AlamitosUnited StatesRecruiting
UCLA Department of Medicine Hematologyoncology
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Los AngelesUnited StatesRecruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
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MiamiUnited StatesRecruiting
Tennessee Oncology, Pllc Nashville
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NashvilleUnited StatesRecruiting
Christiana Care
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NewarkUnited StatesRecruiting
Ochsner Clinic Foundation
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New OrleansUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center Mskcc
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New YorkUnited StatesRecruiting
Weill Cornell Medical College - NewYork-Presbyterian Hospital
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New YorkUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
Kaiser Permanente Oakland Medical Center
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OaklandUnited StatesRecruiting
Texas Oncology-Palestine Cancer Center
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PalestineUnited StatesRecruiting
Stanford Cancer Institute
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Palo AltoUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
Mayo Clinic Phoenix
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PhoenixUnited StatesRecruiting
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
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RoanakeUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Kaiser Permanente Roseville Medical Center
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RosevilleUnited StatesRecruiting
Kaiser Permanente San Francisco Medical Center Oncology
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San FranciscoUnited StatesRecruiting
Kaiser Permanente Santa Clara Medical Center Oncologyhematology
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Santa ClaraUnited StatesRecruiting
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesRecruiting
Summit Cancer Centers
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SpokaneUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Northwest Medical Specialties
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TacomaUnited StatesRecruiting
Kaiser Permanente Northern California
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VallejoUnited StatesRecruiting
Kaiser Permanente Walnut Creek Medical Center
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Walnut CreekUnited StatesRecruiting
MedStar Georgetown University Hospital
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Washington D.C.United StatesRecruiting
Mission Cancer and Blood
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WaukeeUnited StatesRecruiting
The University of Kansas Cancer Center
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WestwoodUnited StatesRecruiting
Atrium Health Wake Forest Baptist
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.