Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
QuANTUM-First
A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
3 other identifiers
interventional
539
28 countries
244
Brief Summary
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2016
Longer than P75 for phase_3
244 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2021
CompletedResults Posted
Study results publicly available
October 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2023
CompletedAugust 6, 2024
July 1, 2024
5 years
January 22, 2016
August 12, 2022
August 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Overall survival is defined as the time from randomization until death from any cause.
Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
Secondary Outcomes (9)
Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)
Number of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)
- +4 more secondary outcomes
Study Arms (2)
Chemotherapy plus quizartinib
EXPERIMENTALInduction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with the experimental drug quizartinib
Chemotherapy plus placebo
ACTIVE COMPARATORInduction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with placebo
Interventions
Eligibility Criteria
You may qualify if:
- Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
- Is ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at Screening);
- Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm, based on the World Health Organization (WHO) 2008 classification (at Screening);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the participant signs their first ICF);
- Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3% FLT3-ITD/total FLT3);
- Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol;
- Adequate renal function defined as:
- a. Creatinine clearance \>50 mL/min, as calculated with the modified Cockcroft Gault equation
- Adequate hepatic function defined as:
- Total serum bilirubin (TBL) ≤1.5 × upper limit of normal (ULN) unless the participant has documented Gilbert's syndrome or the increase is related to increased unconjugated (indirect) bilirubin due to hemolysis;
- Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × ULN;
- Serum electrolytes within normal limits: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia or ionized calcium) and magnesium. If outside of normal limits, participant will be eligible when electrolytes are corrected;
- If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months);
- If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.
You may not qualify if:
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-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 neoplasms;
- Prior treatment for AML, except for the following allowances:
- Leukapheresis;
- Treatment for hyperleukocytosis with hydroxyurea;
- Cranial radiotherapy for central nervous system (CNS) leukostasis;
- Prophylactic intrathecal chemotherapy;
- Growth factor/cytokine support;
- Prior treatment with quizartinib or other FLT3-ITD inhibitors;
- Prior treatment with any investigational drug or device within 30 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures;
- History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for participants with symptoms of CNS leukemia to rule out extramedullary CNS involvement;
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years;
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Bradycardia of less than 50 beats per minute, unless the participant has a pacemaker;
- Fridericia's Heart Rate Correction Formula (QTcF) interval \>450 msec;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (244)
University of Florida (UF) Health Shands Hospital
Gainesville, Florida, 90095, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Franciscan St. Francis Health Indianapolis
Indianapolis, Indiana, 46237, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
NY Medical College - Hudson Valley Hematology Oncology Associates
Valhalla, New York, 10595, United States
Duke Clinical Research Institute
Durham, North Carolina, 27710, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
West Virginia University Hospitals, Inc.
Morgantown, West Virginia, 26506, United States
Sanatorio Britanico
Rosario, Santa Fe Province, S2000CVB, Argentina
Sanatorio Allende
Córdoba, X5000JHQ, Argentina
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Townsville Hospital (TTH)
Douglas, Queensland, 4814, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UCL Mont-Godinne
Yvoir, 5530, Belgium
Hospital Amaral Carvalho
Brasília, 70750-521, Brazil
Hospital do CEPON
Brasília, 70750-521, Brazil
Instituto do Cancer do Estado de São Paulo
Brasília, 70750-521, Brazil
Santa Casa de Misericórdia de Porto Alegre
Brasília, 70750-521, Brazil
Hospital da Cidade de Passo Fundo
Passo Fundo, 99010-260, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Sofia, 1000, Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G-3G3, Canada
Vancouver General Hospital (VGH)
Vancouver, British Columbia, V5Z 1M9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1X5, Canada
Peking University First Hospital
Beijing, 100034, China
The General Hospital of People's Liberation Army (301 Hospital)
Beijing, 100853, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Guangdong General Hospital
Guangzhou, 510030, China
Lanzhou University Second Hospital
Lanzhou, 730030, China
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, 200025, China
West China Hospital, Sichuan University
Taiyuan, 30001, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, 300020, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325015, China
Tang Du Hospital, Fourth Military Medical University
Xi'an, 710038, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Klinička Bolnica Dubrava
Zagreb, 10000, Croatia
Klinička Bolnica Merkur
Zagreb, 10000, Croatia
Klinički Bolnički Centar Zagreb
Zagreb, 10000, Croatia
Fakultní Nemocnice Hradec Králové
Hradec Králové, 500 05, Czechia
Fakultní Nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultní Nemocnice Ostrava
Ostrava, 708 52, Czechia
Fakultni Nemocnice Plzen
Pilsen, 304 60, Czechia
Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)
Prague, 128 20, Czechia
Hospital A. Michallon
Grenoble, 38043, France
Centre Hospitalier de Versailles - Hôpital André Mignot
Le Chesnay, 78150, France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, 59037, France
Centre Léon Bérard
Lyon, 69373, France
L'Institut Paoli - Calmettes
Marguerittes, 13009, France
Hôpital de la Conception
Marseille, 13385, France
CHRU Montpellier - Saint Eloi
Montpellier, 34295, France
Hôpital Saint-Antoine
Paris, 75012, France
Hôpital Saint-Louis
Paris, 75475, France
Hôpital Haut-Lévêque
Pessac, 33604, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
Centre Henri Becquerel - Centre de Lutte Contre le Cancer
Rouen, 76038, France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, 31059, France
HELIOS Klinikum Bad Saarow
Bad Saarow, 15526, Germany
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114, Germany
Marien Hospital Düsseldorf GmbH
Düsseldorf, 40479, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitätsklinikum Halle (Saale)
Halle, 6120, Germany
Evangelisches Krankenhaus Hamm gGmbH
Hamm, 59063, Germany
Medizinische Hochschule Hannover (MHH)
Hannover, 30625, Germany
Universitätsklinikum Münster
Heidelberg, 69115, Germany
Universitätsklinikum Tübingen
Heidelberg, 69115, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Leipzig
Leipzig, 4103, Germany
Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557, Germany
HELIOS Klinikum Wuppertal
Wuppertal, 42283, Germany
Prince of Wales Hospital
Shatin, Hong Kong
Markusovszky Egyetemi Oktatókórház
Budapest, 1051, Hungary
Szegedi Tudományegyetem
Budapest, 1051, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Pecsi Tudomanyegyetem Klinikai Központ
Pécs, 7624, Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, 9700, Hungary
Assaf Harofeh Medical Center
Be’er Ya‘aqov, Tsifrin, 70300, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Hadassah University Medical Center
Jerusalem, 91120, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
Ascoli Piceno, 63100, Italy
Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari
Bari, 70124, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
IRCCS AOU San Martino - IST
Genova, 16132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
A.O.R.N. "A. Cardarelli"
Napoli, 80131, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, 28100, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146, Italy
Ospedale S. Maria delle Croci - Ravenna
Ravenna, 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 133, Italy
Ospedale S. Eugenio
Roma, 133, Italy
Policlinico Tor Vergata
Roma, 133, Italy
IRCCS Ospedale San Raffaele
Roma, 20132, Italy
Azienda Ospedaliero-Universitaria Careggi
Roma, 50134, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Roma, 56126, Italy
Azienda Ospedaliera Universitaria "Federico II"
Roma, 80131, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona
Salerno, 84131, Italy
Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128, Italy
ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese
Varese, 21100, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
University of Fukui Hospital
Yoshida, Fukui, 910-1193, Japan
Kyushu University Hospital
Higashi, Fukuoka, 812-8582, Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Gunma, 371-0821, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Chugoku Central Hospital
Fukuyama, Hiroshima, 720-0001, Japan
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, 003-0006, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miagi, 983-8520, Japan
Tenri Hospital
Tenri, Nara, 632-8552, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677, Japan
The Jikei University Hospital
Minato-Ku, Tokyo, 105-0003, Japan
Akita University Hospital
Akita, 010-8543, Japan
Aomori Prefectural Central Hospital
Aomori, 030-8553, Japan
Chiba Aoba Municipal Hospital
Chiba, 260-0852, Japan
Kameda Medical Center - Kameda General Hospital
Chiba, 296-0041, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Gifu Municipal Hospital
Gifu, 500-8513, Japan
National Hospital Organization Kagoshima Medical Center
Kagoshima, 892-0853, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
NTT Medical Center Tokyo
Tokyo, 141-8625, Japan
Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, 76-200, Poland
Instytut Hematologii i Transfuzjologi
Warsaw, 00-957, Poland
Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu
Warsaw, 50367, Poland
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
Lisbon, 1169050, Portugal
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
Porto, 4099-001, Portugal
Instituto Português Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, 4200-319, Portugal
Institutul Regional de Oncologie Iași
Bucharest, 20125, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Spitalul Clinic Coltea
Bucharest, 20125, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 20125, Romania
Institutul Clinic Fundeni
Bucharest, 22328, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
Cluj-Napoca, 400124, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)
Târgu Mureş, 540042, Romania
Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)
Târgu Mureş, 540136, Romania
Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, 603126, Russia
Penza Regional Oncology Dispensary
Penza, 440071, Russia
Republican Hospital n.a.V.A. Baranov
Petrozavodsk, 185019, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390039, Russia
Russian Research Institute of Hematology and Blood Transfusion
Saint Petersburg, 191024, Russia
Leningrad Regional Clinic and Hospital
Saint Petersburg, 194291, Russia
Almazov Federal North-West Medical Research Centre
Saint Petersburg, 197341, Russia
Saratov State Medical University named after V.I. Razumovsky
Saratov, 410012, Russia
Tula Regional Clinical Hospital
Tula, 300053, Russia
Klinički Centar Srbije
Belgrade, 11000, Serbia
Klinički Centar Niš
Niš, 18000, Serbia
Klinički Centar Vojvodine
Novi Sad, 21101, Serbia
National University Hospital (S) Pte Ltd
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 138543, Singapore
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Gachon University Gil Hospital
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severance Hospital
Seoul, 3722, South Korea
SoonChunHyang University Seoul Hospital
Seoul, 4401, South Korea
Konkuk University Medical Center
Seoul, 5030, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591, South Korea
Korea University Guro Hospital
Seoul, 8308, South Korea
Ajou University Hospital
Sŏwŏn, 16499, South Korea
Ulsan University Hospital (UUH)
Ulsan, 44033, South Korea
Hospital Universitari Son Espases
Palma, Mallorca, 7014, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Complejo Hospitalario Universitario de Albacete - Hospital General Universitario
Albacete, 2006, Spain
Hospital General Universitario de Alicante
Alicante, 3010, Spain
Catalan Institute of Oncology (ICO)
Badalona, 8916, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 8035, Spain
Hospital Clinic i Provincial
Barcelona, 8036, Spain
Hospital Duran i Reynals
Barcelona, 8907, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital San Pedro de Alcántara
Cáceres, 10002, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Complejo Hospitalario Universitario Granada
Granada, 18014, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, 35010, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Quirón Madrid
Madrid, 28223, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, 28222, Spain
Hospital Regional Universitario de Málaga - Hospital General
Málaga, 29010, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Fundación Jiménez Díaz
Pamplona, 31008, Spain
Hospital Clínico Universitario "Lozano Blesa"
Pamplona, 31008, Spain
Hospital General Universitario Morales Meseguer
Pamplona, 31008, Spain
Hospital Universitario Miguel Servet
Pamplona, 31008, Spain
Hospital Álvaro Cunqueiro
Pamplona, 31008, Spain
Hosp Universitario Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Universitari Joan XXIII de Tarragona
Tarragona, 43005, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Hospital Universitari i Politècnic La Fe
Valencia, CP 46026, Spain
Chang Gung Medical Foundation - Kaohsiung Branch
Kaohsiung City, Niaosong District, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan District, 33305, Taiwan
Cherkasy Regional Oncology Dispensary
Cherkasy, 18009, Ukraine
Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho
Poltava, 36011, Ukraine
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
Vinnytsia, 21018, Ukraine
Zhitomir Regional Clinical Hospital
Zhytomyr, 10002, Ukraine
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Related Publications (4)
Levis MJ, Erba HP, Montesinos P, Kim HJ, Vrhovac R, Patkowska E, Zak P, Wang PN, Connolly Rohrbach JE PhD, Chang K, Liu L, Mostafa Kamel Y, Imadalou K, Lesegretain A, Cortes JE, Sekeres MA, Dombret H, Amadori S, Wang J, Schlenk RF, Perl AE. FLT3-ITD measurable residual disease from the QuANTUM-First trial. Blood Adv. 2025 Oct 6:bloodadvances.2025016444. doi: 10.1182/bloodadvances.2025016444. Online ahead of print.
PMID: 41052406DERIVEDSchlenk RF, Montesinos P, Kim HJ, Romero-Aguilar A, Vrhovac R, Patkowska E, Zak P, Wang PN, Hanyok J, Liu L, Kamel YM, Imadalou K, Lesegretain A, Cortes J, Sekeres MA, Dombret H, Amadori S, Wang J, Perl AE, Levis MJ, Erba HP. Impact of hematopoietic cell transplantation and quizartinib in newly diagnosed patients with acute myeloid leukemia and FMS-like tyrosine kinase 3-internal tandem duplications in the QuANTUM-First trial. Haematologica. 2025 Sep 1;110(9):2024-2039. doi: 10.3324/haematol.2024.286623. Epub 2025 Mar 13.
PMID: 40079105DERIVEDErba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Zak P, Wang PN, Mitov T, Hanyok J, Kamel YM, Rohrbach JEC, Liu L, Benzohra A, Lesegretain A, Cortes J, Perl AE, Sekeres MA, Dombret H, Amadori S, Wang J, Levis MJ, Schlenk RF; QuANTUM-First Study Group. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 May 13;401(10388):1571-1583. doi: 10.1016/S0140-6736(23)00464-6. Epub 2023 Apr 25.
PMID: 37116523DERIVEDCortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.
PMID: 29859851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo Inc.
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2016
First Posted
January 29, 2016
Study Start
September 1, 2016
Primary Completion
August 13, 2021
Study Completion
June 16, 2023
Last Updated
August 6, 2024
Results First Posted
October 5, 2022
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/