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NCT03201965CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

Source: ClinicalTrials.gov · Last updated 26 Nov 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
416 (actual)
First submitted
27 Jun 2017
Start date
5 Oct 2017
Primary completion date
14 Feb 2020
Lead sponsor
Janssen Research & Development, LLC
Diseases
Amyloidosis
NCT number
NCT03201965
EU CT number
2024-511967-26-00
EudraCT number
2016-001737-27

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 416
  • From 5 Oct 2017 to the primary completion date, 14 Feb 2020
  • 120 sites in 22 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 therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization
  • Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, \>= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia
  • Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted

Other illness

  • Known to be seropositive for human immunodeficiency virus (HIV)
  • Any one of the following:
    • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (ie, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
    • Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy)

Lab values

  • Evidence of significant cardiovascular conditions as specified below:
    • NT-ProBNP \> 8500 nanogram per liter (ng/L)
    • New York Heart Association (NYHA) classification IIIB or IV heart failure
    • Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram \[ECG\] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy
    • Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 months
    • For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization
    • Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators \[ICD\] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study)
    • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \> 500 milliseconds (msec). Participants who have a pacemaker may be included regardless of calculated QTc interval
    • Supine systolic blood pressure \< 90 millimeter of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of \> 20 mmHg despite medical management (eg, midodrine, fludrocortisones) in the absence of volume depletion

Other

  • Grade 2 sensory or Grade 1 painful peripheral neuropathy

Who the study is looking for

  • Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance
  • Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following:
    • serum monoclonal (M)-protein greater than or equal (\>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation \[IFE\] performed at a central laboratory)
    • serum free light chain greater than or equal to (\>=) 50 milligram/Liter (mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L
  • One or more organs impacted by AL amyloidosis according to consensus guidelines
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

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

Full criteria on ClinicalTrials.gov

Sites (120)

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

SiteCityCountrySite status
Box Hill Hospital
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Box HillAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Institut Jules Bordet
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AnderlechtBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Hospital das Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Sociedade Pernambucana de Combate ao Cancer
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RecifeBrazilUnknown status
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Rio de JaneiroBrazilUnknown status
Hospital Sao Rafael
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SalvadorBrazilUnknown status
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
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São José do Rio PretoBrazilUnknown status
Clinica Sao Germano
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São PauloBrazilUnknown status
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
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São PauloBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da USP
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São PauloBrazilUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Alberta Health Services
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EdmontonCanadaUnknown status
London Health Sciences Center
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LondonCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
University Health Network UHN Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Vancouver General Hospital
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VancouverCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
HOPA MVZ GmbH
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HamburgGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Region Midtjylland
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Aarhus NDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Institut Catala d'Oncologia
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BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceCompleted
Institut Paoli-Calmettes
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MarseilleFranceCompleted
CHRU De Nancy
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Nancy CedexFranceCompleted
Hopital Saint Louis
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ParisFranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceCompleted
University Hospitals Birmingham NHS Trust,
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BirminghamUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceCompleted
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
Carmel Hospital
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HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky Medical Center
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Tel AvivIsraelUnknown status
Assaf Ha'Rofeh Medical Center
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TsrifinIsraelUnknown status
University Hospital Consorziale Policlinico
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BariItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
Fukushima Medical University Hospital
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FukushimaJapanUnknown status
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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HiroshimaJapanUnknown status
Teine Keijinkai Hospital
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HokkaidoJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Kumamoto University Hospital
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KumamotoJapanUnknown status
Kyoto Kuramaguchi Medical Center
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KyotoJapanUnknown status
Shinshu University Hospital
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MatsumotoJapanUnknown status
Matsuyama Red Cross Hospital
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MatsuyamaJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
National Hospital Organization Okayama Medical Center
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OkayamaJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya CityJapanUnknown status
Tokushima University Hospital
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TokushimaJapanUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Centro de Investigación Farmacéutica Especializada
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GuadalajaraMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Máxima Medisch Centrum
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EindhovenNetherlandsCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Haga Hospital
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's-GravenhageNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Instytut Hematologii I Transfuzjologii
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WarsawPolandCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Winship Cancer Institute, Emory University
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AtlantaUnited StatesUnknown status
University of Colorado
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AuroraUnited StatesUnknown status
University of Maryland
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BaltimoreUnited StatesUnknown status
Boston University Medical Center
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
The Ohio State University
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ColumbusUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Mayo Clinic
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JacksonvilleUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Sarah Cannon Research Institute
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NashvilleUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Weill Cornell Medical College
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New YorkUnited StatesUnknown status
University of Pennsylvania Medical Center
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic - Arizona
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PhoenixUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Seattle Cancer Care Alliance
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SeattleUnited StatesUnknown status
Stanford University
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StanfordUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Wake Forest University Health Sciences - Cardiovascular Medicine
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Winston-SalemUnited StatesUnknown status
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Akdeniz University Medical Faculty
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AntalyaTurkey (Türkiye)Unknown status
Ondokuz Mayis Universitesi Tip Fakultesiy
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AtakumTurkey (Türkiye)Unknown status
Istanbul University Istanbul Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylul Universitesi Tip Fakultesi
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IzmirTurkey (Türkiye)Unknown status
Erciyes University Medical Faculty
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TalasTurkey (Türkiye)Unknown status

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