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NCT04102020CompletedPhase 3

A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
112 (actual)
First submitted
23 Sept 2019
Start date
26 Mar 2020
Primary completion date
29 Sept 2022
Lead sponsor
AbbVie
NCT number
NCT04102020
EU CT number
2023-507221-42-00
EudraCT number
2019-002217-19

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 112
  • From 26 Mar 2020 to the primary completion date, 29 Sept 2022
  • 127 sites in 19 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.

Other illness

  • History of acute promyelocytic leukemia (APL).
  • History of active central nervous system involvement with acute myeloid leukemia (AML).

Who the study is looking for

  • Diagnosis of newly diagnosed acute myeloid leukemia (AML).
  • Participant meets the following disease activity criteria:
    • Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
    • Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
    • AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
  • Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

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

Full criteria on ClinicalTrials.gov

Sites (127)

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

SiteCityCountrySite status
Royal Adelaide Hospital /ID# 238754
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AdelaideAustraliaUnknown status
Box Hill Hospital /ID# 217622
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Box HillAustraliaUnknown status
Barwon Health /ID# 217921
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GeelongAustraliaUnknown status
St George Hospital /ID# 215416
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KogarahAustraliaUnknown status
Liverpool Hospital /ID# 215415
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LiverpoolAustraliaUnknown status
Perth Blood Institute Ltd /ID# 217531
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NedlandsAustraliaUnknown status
Shoalhaven District Memorial Hospital /ID# 221973
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NowraAustraliaUnknown status
Gold coast University Hospital /ID# 214650
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SouthportAustraliaUnknown status
Toowoomba Hospital /ID# 217922
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ToowoombaAustraliaUnknown status
Wollongong Hospital /ID# 216071
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WollongongAustraliaUnknown status
Princess Alexandra Hospital /ID# 238753
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WoolloongabbaAustraliaUnknown status
Tom Baker Cancer Centre /ID# 214625
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CalgaryCanadaUnknown status
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
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EdmontonCanadaUnknown status
Juravinski Cancer Centre /ID# 214623
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HamiltonCanadaUnknown status
London Health Sciences Center- University Hospital /ID# 216055
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LondonCanadaUnknown status
Duplicate_McGill University Health Center Research Institute /ID# 215984
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MontrealCanadaUnknown status
Ottawa Hospital Research Institute /ID# 214627
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OttawaCanadaUnknown status
University Health Network_Princess Margaret Cancer Centre /ID# 214624
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TorontoCanadaUnknown status
Chinese PLA General Hospital /ID# 216286
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BeijingChinaUnknown status
Beijing Friendship Hospital /ID# 216455
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BeijingChinaUnknown status
Peking University International Hospital /ID# 217439
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BeijingChinaUnknown status
West China Hospital, Sichuan University /ID# 216606
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ChengduChinaUnknown status
Guangdong Provincial People's Hospital /ID# 216284
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GuangzhouChinaUnknown status
Nanfang Hospital of Southern Medical University /ID# 215565
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
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HangzhouChinaUnknown status
Duplicate_Shanghai Tongji Hospital /ID# 218800
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ShanghaiChinaUnknown status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
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TianjinChinaUnknown status
Tongji Hospital Tongji Medical College of HUST /ID# 216456
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WuhanChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
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WuhanChinaUnknown status
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
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Xi’anChinaUnknown status
Henan Cancer Hospital /ID# 215566
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Fakultni Nemocnice Ostrava
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PorubaCzechiaCompleted
Institute Of Hematology And Blood Transfusion
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Prague 2CzechiaCompleted
Philipps-Universitaet Marburg
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MarburgGermanyCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Centre Hospitalier de la Cote Basque
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BayonneFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
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BirminghamUnited KingdomUnknown status
University Hospitals Bristol /ID# 215911
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BristolUnited KingdomUnknown status
Cardiff & Vale University Health Board /ID# 215906
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CardiffUnited KingdomUnknown status
Leicester Royal Infirmary /ID# 215924
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LeicesterUnited KingdomUnknown status
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908
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LondonUnited KingdomUnknown status
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909
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LondonUnited KingdomUnknown status
Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921
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LondonUnited KingdomUnknown status
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
Evaggelismos Hospital
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
University of Debrecen
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DebrecenHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryCompleted
Shaare Zedek Medical Center /ID# 239699
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JerusalemIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 239700
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JerusalemIsraelUnknown status
Rabin Medical Center /ID# 239696
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Petah TikvaIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 239698
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Tel AvivIsraelUnknown status
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
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AnconaItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 214841
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FukuokaJapanUnknown status
Kyushu University Hospital /ID# 215286
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FukuokaJapanUnknown status
Saitama Medical University International Medical Center /ID# 214823
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Hidaka-shiJapanUnknown status
Duplicate_National Hospital Organization Mito Medical Center /ID# 214699
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Higashi Ibaraki-gunJapanUnknown status
Duplicate_Nagasaki University Hospital /ID# 214916
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NagasakiJapanUnknown status
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
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NagoyaJapanUnknown status
Aichi Cancer Center Hospital /ID# 215284
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NagoyaJapanUnknown status
Duplicate_Okayama University Hospital /ID# 214840
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OkayamaJapanUnknown status
Osaka Metropolitan University Hospital /ID# 215225
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OsakaJapanUnknown status
Kindai University Hospital /ID# 214915
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Osakasayama-shiJapanUnknown status
Duplicate_Hokkaido University Hospital /ID# 215938
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SapporoJapanUnknown status
Tohoku University Hospital /ID# 214669
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SendaiJapanUnknown status
NTT Medical Center Tokyo /ID# 214959
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Shinagawa-kuJapanUnknown status
Yamagata University Hospital /ID# 214698
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YamagataJapanUnknown status
University of Fukui Hospital /ID# 215283
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Yoshida-gunJapanUnknown status
Duplicate_Pusan National University Hospital /ID# 213941
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BusanSouth KoreaUnknown status
Seoul National University Bundang Hospital /ID# 215549
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Seongnam-siSouth KoreaUnknown status
Seoul National University Hospital /ID# 213943
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 213940
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SeoulSouth KoreaUnknown status
Pan American Center for Oncology Trials, LLC /ID# 214953
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Rio PiedrasPuerto RicoUnknown status
MMCC Kommunarka /ID# 215223
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MoscowRussiaUnknown status
P. Hertsen Moscow Oncology Research Institute /ID# 214312
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MoscowRussiaUnknown status
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
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Nizhny NovgorodRussiaUnknown status
Clinic of Immunopathology, SRIFCI /ID# 217937
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NovosibirskRussiaUnknown status
Almazov National Medical Research Centre /ID# 214306
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Saint PetersburgRussiaUnknown status
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
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Saint PetersburgRussiaUnknown status
Regional Clinical Hospital of Yaroslavl /ID# 214318
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YaroslavlRussiaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital /ID# 213952
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TaichungTaiwanUnknown status
National Taiwan University Hospital /ID# 213939
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Taipei CityTaiwanUnknown status
Linkou Chang Gung Memorial Hospital /ID# 213951
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Taoyuan CityTaiwanUnknown status
St. Alphonsus Regional Medical /ID# 216424
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BoiseUnited StatesUnknown status
Massachusetts General Hospital /ID# 217307
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BostonUnited StatesUnknown status
Tufts Medical Center /ID# 216110
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BostonUnited StatesUnknown status
Duplicate_Rush University Medical Center /ID# 218815
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ChicagoUnited StatesUnknown status
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
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DallasUnited StatesUnknown status
Colorado Blood Cancer Institute /ID# 214280
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DenverUnited StatesUnknown status
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
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Fountain ValleyUnited StatesUnknown status
Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
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GreenvilleUnited StatesUnknown status
St Francis Cancer Center /ID# 216115
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GreenvilleUnited StatesUnknown status
The John Theurer Cancer /ID# 215191
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HackensackUnited StatesUnknown status
University of Texas MD Anderson Cancer Center /ID# 225201
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HoustonUnited StatesUnknown status
University of Kentucky Markey Cancer Center /ID# 215048
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LexingtonUnited StatesUnknown status
University of California, Los Angeles /ID# 219149
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Los AngelesUnited StatesUnknown status
Duplicate_Norton Cancer Institute /ID# 216401
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LouisvilleUnited StatesUnknown status
Mitchell Cancer Institute /ID# 216443
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MobileUnited StatesUnknown status
Tennessee Oncology-Nashville Centennial /ID# 218757
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NashvilleUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey /ID# 239708
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New BrunswickUnited StatesUnknown status
Tulane Medical Center - New Orleans /ID# 218166
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New OrleansUnited StatesUnknown status
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583
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New OrleansUnited StatesUnknown status
Weill Cornell Medical College /ID# 214847
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New YorkUnited StatesUnknown status
Fox Chase Cancer Center /ID# 239372
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PhiladelphiaUnited StatesUnknown status
UPMC Hillman Cancer Ctr /ID# 214051
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PittsburghUnited StatesUnknown status
Providence Portland Medical Ct /ID# 216231
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PortlandUnited StatesUnknown status
Gibbs Cancer Center & Research /ID# 216192
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SpartanburgUnited StatesUnknown status
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
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SpringfieldUnited StatesUnknown status
Saint Louis University Cancer Center /ID# 218164
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St LouisUnited StatesUnknown status
Duplicate_UMass Chan Medical School /ID# 218163
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WorcesterUnited StatesUnknown status
Ankara Univ Medical Faculty /ID# 214239
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AnkaraTurkey (Türkiye)Unknown status
Gulhane Askeri Tip Academy /ID# 214242
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AnkaraTurkey (Türkiye)Unknown status
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525
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IstanbulTurkey (Türkiye)Unknown status
Erciyes University Medical Faculty /ID# 214240
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KayseriTurkey (Türkiye)Unknown status
Karadeniz University /ID# 214241
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TrabzonTurkey (Türkiye)Unknown status

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