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NCT06943872RecruitingPhase 3

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
630 (estimated)
First submitted
17 Apr 2025
Start date
11 Jun 2025
Primary completion date
30 Sept 2029
Lead sponsor
BeOne Medicines
NCT number
NCT06943872
EU CT number
2024-517131-52-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 630
  • From 11 Jun 2025 to the primary completion date, 30 Sept 2029
  • 197 sites in 21 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

  • Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  • Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent

Other illness

  • Severe or debilitating pulmonary disease
  • Clinically significant cardiovascular disease
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Known active prolymphocytic leukemia or currently suspected Richter's transformation
  • Known central nervous system involvement by CLL/SLL

Who the study is looking for

  • Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  • Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
  • Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Adequate organ function

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

Full criteria on ClinicalTrials.gov

Sites (197)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Alemán
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CABAArgentinaRecruiting
FUNDALEU
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CABAArgentinaRecruiting
Instituto Alexander Fleming (Iaf)
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Sunshine Coast Hospital and Health Service
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BirtinyaAustraliaRecruiting
Blacktown Cancer and Haematology Centre
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BlacktownAustraliaRecruiting
Monash Health
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ClaytonAustraliaRecruiting
Rockingham Hospital
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CooloongupAustraliaRecruiting
St Vincents Hospital Melbourne
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FitzroyAustraliaRecruiting
St George Hospital
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KogarahAustraliaRecruiting
Northern Nsw Health District
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LismoreAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
Macquarie University
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North RydeAustraliaRecruiting
GenesisCare - North Shore
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St LeonardsAustraliaRecruiting
Perth Blood Institute
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West PerthAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
CETUS
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Belo HorizonteBrazilActive, not recruiting
Universidade de Campinas Centro de Hematologia E Hemoterapia
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CampinasBrazilActive, not recruiting
Hospital Erasto Gaertner
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CuritibaBrazilActive, not recruiting
Complexo Hospitalar de Niteroi
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NiteróiBrazilActive, not recruiting
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
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Porto AlegreBrazilActive, not recruiting
Hospital Sao Lucas
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Rio de JaneiroBrazilActive, not recruiting
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
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Rio de JaneiroBrazilActive, not recruiting
Hospital Santa Izabel
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SalvadorBrazilActive, not recruiting
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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São PauloBrazilActive, not recruiting
Hospital Nove de Julho - dasa
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São PauloBrazilActive, not recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
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São PauloBrazilActive, not recruiting
Hospital Samaritano Sao Paulo
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São PauloBrazilActive, not recruiting
Instituto Brasileiro de Controle Do Câncer
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São PauloBrazilActive, not recruiting
Hospital Santa Rita de Cassia Afecc
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VitóriaBrazilActive, not recruiting
Arthur Je Child Comprehensive Cancer Centre
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CalgaryCanadaRecruiting
Cross Cancer Institute
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EdmontonCanadaRecruiting
Ciusss Nim Hscm
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MontrealCanadaRecruiting
The Ottawa Hospital
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OttawaCanadaRecruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
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QuébecCanadaRecruiting
Newfoundland and Labrador Health Services
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St. John'sCanadaRecruiting
Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
British Columbia Cancer Agency the Vancouver Centre
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VancouverCanadaRecruiting
CancerCare Manitoba
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WinnipegCanadaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaRecruiting
Fujian Provincial Hospital
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FuzhouChinaRecruiting
Fujian Medical University Union Hospitalqishan Branch
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FuzhouChinaRecruiting
Guangzhou First Peoples Hospital
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GuangzhouChinaRecruiting
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaRecruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaRecruiting
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaRecruiting
Shandong Provincial Hospital
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JinanChinaRecruiting
Jining No1 Peoples Hospital West Branch
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JiningChinaRecruiting
Jiangxi Cancer Hospital
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NanchangChinaRecruiting
Zhongda Hospital Southeast University
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NanjingChinaRecruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
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NanningChinaRecruiting
The Affiliated Peoples Hospital of Ningbo University
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NingboChinaRecruiting
The Affiliated Hospital of Qingdao University Branch West Coast
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QingdaoChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Affiliated Zhongshan Hospital of Fudan University
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ShanghaiChinaRecruiting
Liaoning Cancer Hospital and Institute
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ShenyangChinaRecruiting
The First Hospital of China Medical University
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ShenyangChinaRecruiting
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaRecruiting
Taihe Hospital
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ShiyanChinaRecruiting
Suzhou Municipal Hospitalbaita Branch
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SuzhouChinaRecruiting
Taizhou Hospital of Zhejiang Province (East)
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TaizhouChinaRecruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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TianjinChinaRecruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaRecruiting
Affiliated Hospital of Jiangnan University South Campus
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WuxiChinaRecruiting
The First Affiliated hospital of Xiamen University
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XiamenChinaRecruiting
Shaanxi Provincial Peoples Hospital
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Xi'anChinaRecruiting
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaRecruiting
Northern Jiangsu Peoples hospital
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YangzhouChinaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Institute of Hematology and Blood Transfusion
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PragueCzechiaRecruiting
Onkologische Schwerpunktpraxis Kurfürstendamm
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BerlinGermanyRecruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
Gemeinschaftspraxis Haematologie Onkologie
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DresdenGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
LMU Klinikum Muenchen AöR
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MunichGermanyRecruiting
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
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MutlangenGermanyRecruiting
Diakonie Klinikum Dietrich Bonhoeffer GmbH
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NeubrandenburgGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Haematologisch Onkologische Schwerpunktpraxis
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WuerzburgGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Region Sjaelland
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RoskildeDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital Universitario Infanta Leonor
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MadridSpainRecruiting
Hospital Costa del Sol
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MarbellaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospital Universitario Virgen De Valme
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SevillaSpainRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceRecruiting
Centre Hospitalier Universitaire De Rennes
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Rennes Cedex 9FranceRecruiting
Centre Henri Becquerel
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RouenFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
University Hospitals Dorset Royal Bournemouth Hospital
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BournemouthUnited KingdomRecruiting
Oxford University Hospitals Nhs Trust Churchill Hospital
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HeadingtonUnited KingdomRecruiting
St Jamess University Hospital
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LeedsUnited KingdomRecruiting
Kings College Hospital
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LondonUnited KingdomRecruiting
Clatterbridge Cancer Centre
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Metropolitan Borough of WirralUnited KingdomRecruiting
Freeman Hospital
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Newcastle upon TyneUnited KingdomRecruiting
Royal Cornwall Hospitalsnhs Trust
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TruroUnited KingdomRecruiting
Mater Misericordiae University Hospital
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Dublin 7IrelandRecruiting
St James's Hospital
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Dublin 8IrelandRecruiting
University Hospital Galway
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GalwayIrelandRecruiting
University Hospital Limerick
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LimerickIrelandRecruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
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BariItalyRecruiting
ARNAS G. Brotzu
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CagliariItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
ASL di Salerno - PO Andrea tortora
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PaganiItalyRecruiting
Samsung Medical Center
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GangnamGuSouth KoreaRecruiting
National Cancer Center (Korea)
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IlsandongGu GoyangSiSouth 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
Flevoziekenhuis Stichting
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AlmereNetherlandsRecruiting
Rijnstate Ziekenhuis Stichting
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ArnhemNetherlandsRecruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsRecruiting
Tergooiziekenhuizen
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HilversumNetherlandsRecruiting
North Shore Hospital
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AucklandNew ZealandRecruiting
Auckland City Hospital
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AucklandNew ZealandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
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TorunPolandRecruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GothenburgSwedenRecruiting
Lund University Hospital
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LundSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Uppsala University Hospital
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UppsalaSwedenRecruiting
Rocky Mountain Cancer Centers (Williams) - USOR
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AuroraUnited StatesRecruiting
The University of Maryland Greenebaum Comprehensive Cancer Center
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BaltimoreUnited StatesRecruiting
Mary Bird Perkins Cancer Center
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Baton RougeUnited StatesRecruiting
Beth Israel Deaconess Medical Center (BIDMC)
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BostonUnited 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
Levine Cancer Center
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CharlotteUnited StatesRecruiting
Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
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ChattanoogaUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Oncology Hematology Care Clinical Trials LLC
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CincinnatiUnited StatesRecruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesRecruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
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EugeneUnited StatesRecruiting
The Cancer and Hematology Centers
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Grand RapidsUnited StatesRecruiting
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesRecruiting
UCI Health - Laguna Hills
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Laguna HillsUnited StatesRecruiting
University of Louisville Brown Cancer Center
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LouisvilleUnited StatesRecruiting
Tennessee Oncology
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NashvilleUnited StatesRecruiting
Yale University, Yale Cancer Center
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New HavenUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center Mskcc
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New YorkUnited StatesRecruiting
Illinois Cancer Specialists (Niles) Usor
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NilesUnited StatesRecruiting
Eastern Connecticut Hematology and Oncology
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NorwichUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Stanford Cancer Institute
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Palo AltoUnited StatesRecruiting
Thomas Jefferson University
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PhiladelphiaUnited StatesRecruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
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PittsburghUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
Texas Oncology - San Antonio Medical Center - USOR
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San AntonioUnited StatesRecruiting
Scripps Prebys Cancer Center
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San DiegoUnited StatesRecruiting
CHRISTUS St. Vincent Regional Cancer Center
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Santa FeUnited StatesRecruiting
Swedish Medical Center Swedish Cancer Institute First Hill Campus
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SeattleUnited StatesRecruiting
Sidney Kimmel Comprehensive Cancer Center Washington Twp
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SewellUnited StatesRecruiting
Texas Oncology - Tyler
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TylerUnited StatesRecruiting
Northwest Cancer Specialist, Pc(Us Oncology Research)
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VancouverUnited StatesRecruiting
Mission Cancer and Blood
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WaukeeUnited StatesRecruiting
Optum Medical Care, PC
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WestburyUnited StatesRecruiting
Cleveland Clinic Florida
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WestonUnited 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.