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Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
Study Purpose
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 2 Years - 20 Years |
| Gender | All |
Inclusion: 1. Histologically confirmed relapsed or refractory solid tumor as follows:
- - For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas).
- - For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma.
- - For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement.
- - Absolute neutrophil count ≥1000/mm3; - Platelet count ≥75,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry); - Hemoglobin ≥8.5 g/dL (transfusion allowed).
- - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver; - Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.
- - Measurable tumor by CT or MRI that is avid on MIBG scan or demonstrates increased FDG uptake on PET scan; - Avid lesion on MIBG scan with positive uptake at a minimum of one site; - For disease that is not avid by MIBG-scan, at least one lesion that demonstrates increased FDG uptake on PET scan AND viable neuroblastoma confirmed by current or prior biopsy; - bone marrow involvement with more than 5% neuroblastoma cells in at least one sample from bilateral bone marrow biopsies; - In non MIBG-avid refractory soft tissue disease that does not demonstrate increased FDG uptake; lesion biopsy is required to document the presence of viable neuroblastoma, unless patient has a new soft tissue lesion (radiographic evidence of disease progression).
- - History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible; - Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes); - Diagnosed or suspected congenital or acquired prolonged QT syndrome; - Need for medications known to prolong the QT interval; - Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval; - Left ventricular ejection fraction <50% or shortening fraction <28%.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03709680 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Pfizer |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Pfizer CT.gov Call Center |
| Principal Investigator Affiliation | Pfizer |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
| Overall Status | Active, not recruiting |
| Countries | Brazil, Canada, Czechia, France, Germany, India, Poland, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma |
| Study Website: | View Trial Website |
Arms
Experimental: Phase 2 Arm A
Palbociclib in combination with irinotecan and temozolomide.
Experimental: Phase 1
Palbociclib in combination with temozolomide and irinotecan and/or with topotecan and cyclophosphamide.
Active Comparator: Phase 2 Arm B
Irinotecan and temozolomide alone.
Experimental: Phase 1 Tumor specific cohort - Neuroblastoma
Palbociclib in combination with topotecan and cyclophosphamide.
Interventions
Drug: - Palbociclib
Phase 1: Administered (oral) at 55 mg/m2, 75 mg/m2, or 40 mg/m2, or 95 mg/m2 or 115 mg/m2 on days 1-14 of a 21-day cycle Phase 1 Tumor specific cohort-Neuroblastoma and Phase 2 : Administered (oral) at 75 mg/m2 on days 1-14 of a 21-day cycle
Drug: - Temozolomide
Phase 1 and Phase 2: Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle
Drug: - Irinotecan
Phase 1 and Phase 2: Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Drug: - Topotecan
Phase 1 only : Administered at 0.75 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Drug: - Cyclophosphamide
Phase 1 only: Administered at 250 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham/Children's of Alabama
Birmingham 4049979, Alabama 4829764, 35233
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Address
Phoenix Children's Hospital
Phoenix 5308655, Arizona 5551752, 85016
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Address
MemorialCare Health System - Long Beach Medical Center
Long Beach 5367929, California 5332921, 90806
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Address
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, 90027
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Address
Children's Hospital and Research Center at Oakland
Oakland 5378538, California 5332921, 94609
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Address
Children's Hospital of Orange County
Orange 5379513, California 5332921, 92868
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Address
Lucile Packard Children's Hospital
Palo Alto 5380748, California 5332921, 94304
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Address
UCSF Medical Center
San Francisco 5391959, California 5332921, 94158
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University of California San Francisco,
San Francisco 5391959, California 5332921, 94158
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Children's Hospital Colorado
Aurora 5412347, Colorado 5417618, 80045
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Address
Children's National Hospital
Washington D.C. 4140963, District of Columbia 4138106, 20010
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UF Health Shands Hospital
Gainesville 4156404, Florida 4155751, 32610
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Address
University of Florida College of Medicine
Gainesville 4156404, Florida 4155751, 32610
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Address
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751, 33701
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Address
Johns Hopkins All Children's Outpatient Care Center
St. Petersburg 4171563, Florida 4155751, 33701
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Address
Johns Hopkins All Children's Hospital
Tampa 4174757, Florida 4155751, 33612
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Address
Children's Healthcare of Atlanta at Egleston
Atlanta 4180439, Georgia 4197000, 30322
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Address
Children's Healthcare of Atlanta at Scottish Rite
Atlanta 4180439, Georgia 4197000, 30342
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Address
Children's Healthcare of Atlanta, Medical Office Building
Atlanta 4180439, Georgia 4197000, 30342
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Address
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861, 60611
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Indiana University
Indianapolis 4259418, Indiana 4921868, 46202
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Address
Norton Children's Hospital
Louisville 4299276, Kentucky 6254925, 40202
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Address
Novak Center for Children's Health
Louisville 4299276, Kentucky 6254925, 40202
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Address
Johns Hopkins University
Baltimore 4347778, Maryland 4361885, 21287
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Address
University of Michigan Health System
Ann Arbor 4984247, Michigan 5001836, 48109
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Address
University of Minnesota Masonic Children's Hospital
Minneapolis 5037649, Minnesota 5037779, 55454
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Address
University of Minnesota Medical Center, Fairview
Minneapolis 5037649, Minnesota 5037779, 55455
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Address
University of Minnesota/Masonic Cancer Center
Minneapolis 5037649, Minnesota 5037779, 55455
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Address
University of Minnesota
Minneapolis 5037649, Minnesota 5037779, 55455
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Address
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296, 39216
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Address
Children's Mercy Hospital
Kansas City 4393217, Missouri 4398678, 64108
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Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
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Address
Robert Wood Johnson University Hospital
New Brunswick 5101717, New Jersey 5101760, 08901
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Address
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760, 08903
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Address
John R. Oishei Childrens Hospital
Buffalo 5110629, New York 5128638, 14203
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Address
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, 14263
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Address
Cohen Children's Medical Center
New Hyde Park 5128514, New York 5128638, 11040
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Address
Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital
New York 5128581, New York 5128638, 10032
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Montefiore Medical Center
The Bronx 5110266, New York 5128638, 10467
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Address
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418, 45229
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University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418, 44106
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Address
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418, 43205
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Cincinnati Children's Liberty Campus
Liberty Township 7126297, Ohio 5165418, 45044
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University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379, 73104
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Address
Oregon Health & Science University
Portland 5746545, Oregon 5744337, 97239
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Address
Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927, 17033
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Address
Buerger Center for Advanced Pediatric Care
Philadelphia 4560349, Pennsylvania 6254927, 19104
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Address
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, 19104
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Address
UPMC Children's Hospital of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927, 15224
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Address
Children's Blood and Cancer Center
Austin 4671654, Texas 4736286, 78723
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Address
Dell Children's Medical Center
Austin 4671654, Texas 4736286, 78723
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Address
Children's Medical Center Dallas
Dallas 4684888, Texas 4736286, 75235
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Address
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286, 76104
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Address
Cook Children's H/O Infusion Center
Grapevine 4694568, Texas 4736286, 76051
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Address
Texas Children's Hospital
Houston 4699066, Texas 4736286, 77030
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Address
Children's Medical Center Plano
Plano 4719457, Texas 4736286, 75024
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Address
Intermountain - Primary Children's Hospital
Salt Lake City 5780993, Utah 5549030, 84113
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Address
Primary Children's Hospital Outpatient Services
Salt Lake City 5780993, Utah 5549030, 84113
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Address
Children's Hospital of The King's Daughters
Norfolk 4776222, Virginia 6254928, 23507
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Address
Children's Hospital of Richmond at VCU
Richmond 4781708, Virginia 6254928, 23219
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Address
Seattle Children's Hospital
Seattle 5809844, Washington 5815135, 98105
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Address
Children's Wisconsin
Milwaukee 5263045, Wisconsin 5279468, 53226
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Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, 53226
International Sites
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Address
Hospital Pequeno Principe / A ssociacao Hospitalar de Protecao a Infancia
Curitiba 3464975, Paraná 3455077, 80250-060
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Address
Hospital Pequeno Príncipe
Curitiba 3464975, Paraná 3455077, 80250-060
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Address
Hospital de Clinicas de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90035-903
Status
Address
Hospital de Clinicas de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90410000
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Address
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos 3470451, São Paulo 3448433, 14784400
Status
Address
Instituto Nacional de Câncer - INCA
Rio de Janeiro 3451190, , 20230-130
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Address
Hospital Santa Marcelina
São Paulo 3448439, , 08270-070
Status
Address
Alberta Children's Hospital
Calgary 5913490, Alberta 5883102, T3B 6A8
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Address
Stollery Children's Hospital
Edmonton 5946768, Alberta 5883102, T6G 2B7
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Address
The Hospital for Sick Children
Toronto 6167865, Ontario 6093943, M5G 1X8
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Address
CHU Sainte-Justine
Montreal 6077243, Quebec 6115047, H3T 1C5
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Address
Detska nemocnice FN Brno
Brno 3078610, Brno-město, 613 00
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Address
Fakultni nemocnice v Motole
Prague 3067696, Praha 5, 150 06
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Address
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux 3031582, Aquitaine, 33076
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Address
Centre Leon Berard
Lyon 2996944, Auvergne-Rhône-Alpes 11071625, 69008
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Centre Leon Berard
Lyon 2996944, Auvergne-Rhône-Alpes 11071625, 69373 CEDEX 08
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Address
Gustave Roussy
Villejuif 2968705, Val-de-marne, 94800
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Address
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille 2995469, , 13385
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Address
Universitätsklinikum Essen
Essen 2928810, North Rhine-Westphalia 2861876, 45122
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Address
Artemis hospital
Gurugram 1270642, Haryana 1270260, 122001
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Address
All India Institute of Medical Sciences
New Delhi 1261481, National Capital Territory of Delhi 1273293, 110029
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Rajiv Gandhi Cancer Institute And Research Centre
New Delhi 1261481, National Capital Territory of Delhi 1273293, 110085
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Instytut Matki i Dziecka
Warsaw 756135, Masovian Voivodeship 858787, 01-211
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Address
Detska fakultna nemocnica s poliklinikou Banska Bystrica
Banská Bystrica 3061186, , 974 09
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Narodny ustav detskych chorob
Bratislava 3060972, , 83340
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National Cancer Center
Goyang-si 1842485, Kyǒnggi-do, 10408
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Address
Seoul National University Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul], 03080
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Asan Medical Center
Seoul 1835848, Seoul-teukbyeolsi [seoul], 05505
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Address
Samsung Medical Center
Seoul 1835848, Seoul-teukbyeolsi [seoul], 06351
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Address
Hospital Universitari Vall d'Hebron
Barcelona 3128760, Barcelona [barcelona], 08035
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Address
Hospital Infantil Universitario Niño Jesús
Madrid 3117735, Madrid, Comunidad de, 28009
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Address
Sahlgrenska Universitetssjukhuset Östra
Gothenburg 2711537, Västra Götalands LÄN [se-14], 416 50
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Address
Ege Universitesi Hastanesi
Izmir 311046, İ̇zmir, 35100
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Address
Hacettepe Universite Hastaneleri
Ankara 323786, , 06100
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Address
Royal Victoria Infirmary
Newcastle upon Tyne 2641673, England 6269131, NE1 4LP
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Address
Royal Hospital for Children
Glasgow 2648579, Scotland 2638360, G51 4TF
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Address
Leeds General Infirmary
Leeds 2644688, , LS1 3EX
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Address
University College London Hospital, NHS Foundation Trust
London 2643743, , NW1 2PG