Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Last updated: February 18, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Treatment

Chemotherapy

Quizartinib

Placebo

Clinical Study ID

NCT06578247
AC220-168
2023-507936-20-00
  • Ages 18-70
  • All Genders

Study Summary

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)-or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) beforeperformance of any trial-specific procedures or tests.

  • ≥18 years or the minimum legal adult age (whichever is greater) and 70 years (atScreening).

  • Newly diagnosed, morphologically documented primary AML based on the World HealthOrganization (WHO) 2016 classification (at Screening)

  • Eastern Cooperative Oncology Group (ECOG) performance status (at the time theparticipant signs their ICF) of 0-2.

  • Participant is receiving standard "7+3" induction chemotherapy regimen as specifiedin the protocol

Exclusion

Key Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia (APL), French-American-Britishclassification M3 or WHO classification of APL with translocation,t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia inblast crisis); participants who undergo diagnostic workup for APL and treatment withall-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).

  • Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasmsor autoimmune/rheumatologic conditions.

  • Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferativeneoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.

  • Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) presentat ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.

  • Prior treatment for AML, except for the following allowances:

  1. Leukapheresis;

  2. Treatment for hyperleukocytosis with hydroxyurea;

  3. Cranial radiotherapy for central nervous system (CNS) leukostasis;

  4. Prophylactic intrathecal chemotherapy;

  5. Growth factor/cytokine support.

Study Design

Total Participants: 700
Treatment Group(s): 3
Primary Treatment: Chemotherapy
Phase: 3
Study Start date:
November 19, 2024
Estimated Completion Date:
June 26, 2030

Study Description

This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Flinders Medical Centre (Fmc)

    Bedford Park, 5042
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, 3128
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, 2139
    Australia

    Site Not Available

  • St Vincent'S Hospital Melbourne

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Townsville University Hospital

    Douglas, 4814
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, 2170
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Perth, 6009
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Ordensklinikum Linz Gmbh - Elisabethinen

    Linz, 4020
    Austria

    Site Not Available

  • Lkh - Universită"Tsklinikum Der Pmu Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • Lkh - Universitătsklinikum Der Pmu Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • Hanusch Krankenhaus Der Wgkk Wien

    Wien, 1140
    Austria

    Site Not Available

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Site Not Available

  • ZNA

    Antwerpen, 2060
    Belgium

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  • Az Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • Uz Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Chu de Liă Ge

    Liege, 4000
    Belgium

    Site Not Available

  • Chu de Liăge

    Liege, 4000
    Belgium

    Site Not Available

  • AZ DELTA

    Roeselare, 8800
    Belgium

    Site Not Available

  • Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, 18618-686
    Brazil

    Site Not Available

  • Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp

    Campinas, 13083-878
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'Ncer

    Curitiba, 81520-060
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Căncer

    Curitiba, 81520-060
    Brazil

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  • Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina

    FlorianĂłpolis, 88034-000
    Brazil

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  • Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina

    FlorianĂłpolis, 88034-000
    Brazil

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  • Huwc - Ufc - Hospital Universită Rio Walter Cantă Dio - Universidade Federal Do Ceară

    Fortaleza, 60430-370
    Brazil

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  • Huwc - Ufc - Hospital Universitărio Walter Cantădio - Universidade Federal Do Ceară

    Fortaleza, 60430-370
    Brazil

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  • Hc-Ufg - Hospital Das Clă Nicas Da Universidade Federal de Goiă S

    Goiania, 74680160
    Brazil

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    Goiania, 74680160
    Brazil

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    Jaú, 17210-120
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    Passo Fundo, 99010-260
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    Passo Fundo, 99010-260
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    Porto Alegre, 90160-093
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    Porto Alegre, 90035-903
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    Porto Alegre, 90035-903
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    Porto Alegre, 90035-074
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    Porto Alegre, 90035-074
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    Rio de Janeiro, 20230-130
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    Rio de Janeiro, 20230-130
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    Pleven, 5800
    Bulgaria

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    Plovdiv, 4002
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    Sofia, 1431
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    Sofia, 1431
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    Stara Zagora, 6000
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    Shanghai, 200050
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    Tianjin, 300020
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    Wenzhou, 325015
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    Zhengzhou, 450008
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    Rijeka, 51000
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    Zagreb, 10000
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  • Clinical Hospital Dubrava

    Zagreb, 10000
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  • Fakultni Nemocnice Brno

    Brno, 625 00
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  • Fakultni Nemocnice Hradec Kralove

    Hradec Kralove, 50005
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  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52
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  • Fakultni Nemocnice Plzen

    Plzen, 304 60
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  • Fakultni Nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

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  • Ustav Hematologie A Krevni Transfuze

    Praha 2, 12800
    Czechia

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  • Chu Angers - Hă"Pital Hă"Tel Dieu

    Angers, 49033
    France

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    Angers, 49033
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    Caen, 14033
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    Grenoble, 38043
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    Grenoble, 38043
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    Le Chesnay Cedex, 78150
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    Lille cedex, 59037
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    Lyon, 69008
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    Marseille Cedex 05, 13005
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  • Chu de Nantes - Hotel Dieu

    Nantes cedex 1, 44093
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    Nice, 06200
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    Nice, 06200
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    Paris cedex 10, 75475
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    Paris cedex 10, 75475
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    Pessac cedex, 33604
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    Pessac cedex, 33604
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  • Centre Hospitalier Lyon Sud

    Pierre BĂŠnite, 69495
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    Rennes cedex 09, 35000
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    Salouel, 80480
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  • Institut de Cancă Rologie de Strasbourg Europe - Icans

    Strasbourg, 67200
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    Strasbourg, 67200
    France

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  • Institut Universitaire Du Cancer de Toulouse- Iuct-O

    Toulouse, 31059
    France

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  • Klinikum Aschaffenburg-Alzenau

    Alzenau, 63755
    Germany

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  • Staedtisches Klinikum Braunschweig Ggmbh

    Braunschweig, 38114
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  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307
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  • Universitaetsklinikum Essen

    Essen, 45147
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    Hannover, 30459
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    Heidelberg, 69120
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    Kiel, 24105
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    Leipzig, 4103
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  • Universitătsklinikum Leipzig Klinik Făr Hămatologie Internistische Onkologie Hămostaseol

    Leipzig, 4103
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  • Universitaetsklinikum Muenster

    Münster, 48149
    Germany

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  • The University of Hong Kong

    Hong kong,
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  • The Chinese University of Hong Kong (Cuhk)

    Shatin, 00000
    Hong Kong

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  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

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  • Debreceni Egyetem

    Debrecen, 4032
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  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Gyor, 9024
    Hungary

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  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725
    Hungary

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  • Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari

    Bari, 70124
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  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)

    Brescia, 25100
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  • Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst

    Meldola, 47014
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    Milano, 20162
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    Milano, 20132
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    Novara, 28100
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    Palermo, 90146
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    Roma, 168
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    Rome, 133
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    Rozzano, 20089
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    San Giovanni Rotondo, 71013
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    Torino, 10126
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    Torino, 10128
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  • Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese

    Varese, 21100
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  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyo-ku, 113-8677
    Japan

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    Chiba-shi, 260-0852
    Japan

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    Fukuoka, 812-8582
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    Fukuyama,
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    Gifu,
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    Hamamatsu, 431-3192
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    Kamogawa-shi, 296-8602
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    Kanazawa, 920-8641
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    Kumamoto,
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    Maebashi,
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    Matsuyama,
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    Osaka-shi, 543-8555
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    Sapporo, 060-8648
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    Sapporo,
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    Tenri, 632-8552
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    Busan, 48108
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    Busan,
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    Daegu, 42472
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    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Md Anderson Cancer Centre

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28220
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39012
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Seville, 41010
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario Dr. Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    GĂśteborg, 41345
    Sweden

    Site Not Available

  • Skă Nes Universitetssjukhus, Lund

    Lund, 22185
    Sweden

    Site Not Available

  • Akademiska Sjukhuset

    Uppsala, 75185
    Sweden

    Site Not Available

  • Inselspital - Universitaetsspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospitalx

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Taoyuan County, 333
    Taiwan

    Site Not Available

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Site Not Available

  • King'S College Hospital

    London, SE5 9NU
    United Kingdom

    Site Not Available

  • Maidstone Hospital

    Maidstone, ME16 9QQ
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford, OX3 7LJ
    United Kingdom

    Site Not Available

  • Torbay Hospital

    Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

  • City of Hope Phoenix

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • Mayo Clinic - Phoenix

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Ucsf - School of Medicine

    San Francisco, California 94115
    United States

    Site Not Available

  • Stanford University School of Medicine- Parent

    Stanford, California 94305
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Mayo Clinic Hospital

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Florida Hospital Cancer Institute - Kissimmee

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Moffit Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Usf College of Medicine

    Tampa, Florida 33612
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Ochsner Medical Center - New Orleans

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Minnesota Medical School - Twin Cities Campus

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Thomas Jefferson Univ Hosp

    Haddonfield, New Jersey 08033
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center - Main

    New York, New York 10065
    United States

    Site Not Available

  • Upstate University Hospital

    Syracuse, New York 13210
    United States

    Site Not Available

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University (Ohsu)

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Upmc Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Tristar Bone Marrow Transplant

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • South Austin Medical Center

    Austin, Texas 78745
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Uva Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Virginia Commonwealth University (Vcu) Massey Cancer Center

    Richmond, Virginia 23229
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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