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NCT06846671RecruitingPhase 3

A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
250 (estimated)
First submitted
21 Feb 2025
Start date
10 Apr 2025
Primary completion date
15 May 2028
Lead sponsor
BeOne Medicines
NCT number
NCT06846671
EU CT number
2024-518893-15-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 250
  • From 10 Apr 2025 to the primary completion date, 15 May 2028
  • 132 sites in 14 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 transplant or chimeric antigen receptor-T cell therapy in the last 3 months
  • Prior exposure to any BTK protein degraders

Other illness

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
  • Clinically significant cardiovascular disease
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Known central nervous system involvement

Who the study is looking for

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
  • Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
  • Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  • Adequate liver function
  • Adequate blood clotting function

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

Full criteria on ClinicalTrials.gov

Sites (132)

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

SiteCityCountrySite status
CEMIC
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CABAArgentinaRecruiting
FUNDALEU
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CABAArgentinaRecruiting
Hospital Alemán
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CABAArgentinaRecruiting
Instituto Alexander Fleming (Iaf)
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Cice 9 de Julio Sanatorio 9 de Julio
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San Miguel de TucumánArgentinaRecruiting
Flinders Medical Centre
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Bedford PKAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
Gosford Hospital
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GosfordAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
Port Macquarie Base Hospital
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Port MacquarieAustraliaRecruiting
Prince of Wales Hospital
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RandwickAustraliaRecruiting
Toowoomba Hospital
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ToowoombaAustraliaRecruiting
Perth Blood Institute
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West PerthAustraliaRecruiting
CETUS
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Belo HorizonteBrazilRecruiting
Hospital Sirio Libanes Brasilia
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BrasíliaBrazilRecruiting
Hospital Erasto Gaertner
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CuritibaBrazilRecruiting
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
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FlorianópolisBrazilRecruiting
Instituto Joinvilense de Hematologia e Oncologia
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JoinvilleBrazilRecruiting
Complexo Hospitalar de Niteroi
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NiteróiBrazilRecruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
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Porto AlegreBrazilRecruiting
Hospital Sao Lucas Dasa Oncologia
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Rio de JaneiroBrazilRecruiting
Oncoclinicas Rio de Janeiro Sa
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Rio de JaneiroBrazilRecruiting
Hospital Sao Rafael (Rede Dor)
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SalvadorBrazilRecruiting
Instituto Brasileiro de Controle Do Câncer
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São PauloBrazilRecruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
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São PauloBrazilRecruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilRecruiting
Hospital Santa Rita de Cassia Afecc
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VitóriaBrazilRecruiting
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
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Greenfield ParkCanadaRecruiting
Juravinski Cancer Centre
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HamiltonCanadaRecruiting
London Health Sciences Centre
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LondonCanadaRecruiting
Jewish General Hospital
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MontrealCanadaRecruiting
The Ottawa Hospital Cancer Centre
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OttawaCanadaRecruiting
Unite de Recherche Clinique Du Cisss Des Laurentides
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SaintJeromeCanadaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyRecruiting
Praxis am Volkspark
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BerlinGermanyRecruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Centrum für Hämatologie und Onkologie Bethanien
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FrankfurtGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaet Des Saarlandes
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HomburgGermanyRecruiting
Institut fuer Versorgungsforschung in der Onkologie GbR
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KoblenzGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
Aberdeen Royal Infirmary
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AberdeenUnited KingdomRecruiting
Birmingham Heartlands Hospital
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BirminghamUnited KingdomRecruiting
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
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BournemouthUnited KingdomRecruiting
Royal Marsden Hospital
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LondonUnited KingdomRecruiting
University College Hospital
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LondonUnited KingdomRecruiting
Southampton General Hospital
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SouthamptonUnited KingdomRecruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Azienda Ospedaliera di Perugia
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PerugiaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Hyogo Prefectural Amagasaki General Medical Center
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AmagasakiCityJapanRecruiting
Tokyo Metropolitan Komagome Hospital
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BunkyokuJapanRecruiting
Chiba Cancer Center
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ChibaJapanRecruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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HiroshimaJapanRecruiting
Kagoshima University Hospital
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KagoshimaJapanRecruiting
Saitama Medical Center
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KawagoeshiJapanRecruiting
Kumamoto University Hospital
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KumamotoJapanRecruiting
Kurashiki Central Hospital
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KurashikishiJapanRecruiting
University Hospital, Kyoto Prefectural Univ of Medicine
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KyotoShiJapanRecruiting
NHO Shikoku Cancer Center
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MatsuyamaJapanRecruiting
Aichi Cancer Center Hospital Clinical Oncology
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NagoyaJapanRecruiting
Niigata University Medical and Dental Hospital
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NiigataJapanRecruiting
National Hospital Organization Okayama Medical Center
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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
Tohoku University Hospital
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SendaiJapanRecruiting
Ntt Medical Center Tokyo
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ShinagawakuJapanRecruiting
Samsung Medical Center
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GangnamGuSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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HwasunGunSouth KoreaRecruiting
National Cancer Center (Korea)
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IlsandongGu GoyangSiSouth KoreaRecruiting
Kyungpook National University Hospital
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JungguSouth KoreaRecruiting
The Catholic University of Korea, Seoul St Marys Hospital
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SeochoGuSouth KoreaRecruiting
Dong A University Hospital
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SeoguSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandRecruiting
Pratia S.A.
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CracowPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Northside Cancer Center
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AtlantaUnited StatesRecruiting
Emory University/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Rocky Mountain Cancer Centers (Williams) - USOR
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AuroraUnited StatesRecruiting
Our Lady of the Lake Hospital
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Baton RougeUnited StatesRecruiting
American Oncology Partners of Maryland, PA
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BethesdaUnited StatesRecruiting
St. Vincent Frontier Cancer Center
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BillingsUnited StatesRecruiting
St Lukes Center For Cancer Care
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ChesterfieldUnited StatesRecruiting
University Hospitals
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ClevelandUnited StatesRecruiting
Dayton Physician Network
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DaytonUnited StatesRecruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
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EugeneUnited StatesRecruiting
Florida Oncology and Hematology
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Fort MyersUnited StatesRecruiting
Intermountain Health Lutheran Hospital Cancer Center of Colorado
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GoldenUnited StatesRecruiting
Corewell Health the Michigan Cancer Consortium
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Grand RapidsUnited StatesRecruiting
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesRecruiting
St. Bernards Medical Center
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JonesboroUnited StatesRecruiting
UCLA Department of Medicine Hematologyoncology
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Los AngelesUnited StatesRecruiting
University of Minnesota
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MinneapolisUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center Mskcc
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New YorkUnited StatesRecruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
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OmahaUnited StatesRecruiting
West Penn Hospital
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PittsburghUnited StatesRecruiting
Scripps Prebys Cancer Center
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San DiegoUnited StatesRecruiting
New York Cancer and Blood Specialists
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ShirleyUnited StatesRecruiting
Oncology Hematology Associates
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SpringfieldUnited StatesRecruiting
Baylor Scott and White Health
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TempleUnited StatesRecruiting
Texas Oncology - Tyler
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TylerUnited StatesRecruiting
Optum Medical Care, PC
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WestburyUnited StatesRecruiting
Cleveland Clinic Florida
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WestonUnited StatesRecruiting
PIH Health Whittier Hospital
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WhittierUnited StatesRecruiting
Cancer Care Associates of York
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YorkUnited StatesRecruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Recruiting
Gazi University
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AnkaraTurkey (Türkiye)Recruiting
Dokuz Eylul University
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BalçovaTurkey (Türkiye)Recruiting
Antalya Memorial Hospital
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DokumaTurkey (Türkiye)Recruiting
Sakarya Training and Research Hospital
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SakaryaTurkey (Türkiye)Recruiting

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