Acute Myeloid Leukemia Clinical Trial
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
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.
Full Description
This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
History of second (Mobitz II) or third degree heart block (participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
History of New York Heart Association Class 3 or 4 heart failure;
Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
Complete left bundle branch block;
Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C);
Known history of human immunodeficiency virus (HIV). Participants should be tested for HIV prior to Randomization if required by local regulations or EC;
History of hypersensitivity to any excipients in the quizartinib/placebo tablets;
Females who are pregnant or breastfeeding;
Otherwise considered inappropriate for the study by the Investigator.
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There are 223 Locations for this study
Gainesville Florida, 90095, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46237, United States
Lexington Kentucky, 40536, United States
Hackensack New Jersey, 07601, United States
Valhalla New York, 10595, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Morgantown West Virginia, 26506, United States
Rosario Santa Fe, S2000, Argentina
Córdoba , X5000, Argentina
Waratah New South Wales, 2298, Australia
Douglas Queensland, 4814, Australia
Woolloongabba Queensland, 4102, Australia
Murdoch Western Australia, 6150, Australia
Brugge , 8000, Belgium
Gent , 9000, Belgium
Yvoir , 5530, Belgium
Brasília , 70750, Brazil
Brasília , 70750, Brazil
Brasília , 70750, Brazil
Brasília , 70750, Brazil
Passo Fundo , 99010, Brazil
Porto Alegre , 90035, Brazil
Pleven , 5800, Bulgaria
Sofia , 1000, Bulgaria
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G-3, Canada
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5G 1, Canada
Beijing , 10003, China
Beijing , 10085, China
Fuzhou , 35000, China
Guangzhou , 51003, China
Lanzhou , 73003, China
Shanghai , 20002, China
Taiyuan , 30001, China
Tianjin , 30002, China
Wenzhou , 32501, China
Xi'an , 71003, China
Zhengzhou , 45000, China
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Ostrava , 708 5, Czechia
Plzen , 304 6, Czechia
Praha 2 , 128 2, Czechia
Grenoble , 38043, France
Le Chesnay , 78150, France
Lille , 59037, France
Lyon , 69373, France
Marguerittes , 13009, France
Marseille , 13385, France
Montpellier , 34295, France
Paris , 75012, France
Paris , 75475, France
Pessac , 33604, France
Pierre Benite , 69495, France
Rouen , 76038, France
Toulouse , 31059, France
Bad Saarow , 15526, Germany
Berlin , 10117, Germany
Braunschweig , 38114, Germany
Düsseldorf , 40479, Germany
Essen , 45122, Germany
Frankfurt am Main , 60590, Germany
Halle , 6120, Germany
Hamm , 59063, Germany
Hannöver , 30625, Germany
Heidelberg , 69115, Germany
Heidelberg , 69115, Germany
Heidelberg , 69120, Germany
Leipzig , 4103, Germany
Mutlangen , 73557, Germany
Wuppertal , 42283, Germany
Shatin , , Hong Kong
Budapest , 1051, Hungary
Budapest , 1051, Hungary
Budapest , 1083, Hungary
Debrecen , 4032, Hungary
Pécs , 7624, Hungary
Szombathely , 9700, Hungary
Be'er Ya'aqov Tsifrin, 70300, Israel
Haifa , 31048, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petaẖ Tiqwa , 49100, Israel
Ramat-Gan , 52621, Israel
Tel Aviv , 64239, Israel
Alessandria , 15121, Italy
Ascoli Piceno , 63100, Italy
Bari , 70124, Italy
Bologna , 40138, Italy
Genova , 16132, Italy
Milano , 20162, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Orbassano , 10043, Italy
Palermo , 90146, Italy
Ravenna , 48121, Italy
Roma , 133, Italy
Roma , 133, Italy
Roma , 133, Italy
Roma , 20132, Italy
Roma , 50134, Italy
Roma , 56126, Italy
Roma , 80131, Italy
Rozzano , 20089, Italy
Salerno , 84131, Italy
Siena , 53100, Italy
Torino , 10126, Italy
Torino , 10128, Italy
Varese , 21100, Italy
Nagoya Aichi, 460-0, Japan
Nagoya Aichi, 466-8, Japan
Toyohashi Aichi, 441-8, Japan
Matsuyama Ehime, 790-0, Japan
Yoshida Fukui, 910-1, Japan
Higashi Fukuoka, 812-8, Japan
Maebashi Gunma, 371-0, Japan
Maebashi Gunma, 371-8, Japan
Fukuyama Hiroshima, 720-0, Japan
Sapporo Hokkaido, 003-0, Japan
Yokohama Kanagawa, 236-0, Japan
Sendai Miagi, 983-8, Japan
Tenri Nara, 632-8, Japan
Hamamatsu Shizuoka, 431-3, Japan
Bunkyō-Ku Tokyo, 113-8, Japan
Minato-Ku Tokyo, 105-0, Japan
Akita , 010-8, Japan
Aomori , 030-8, Japan
Chiba , 260-0, Japan
Chiba , 296-0, Japan
Fukuoka , 811-1, Japan
Gifu , 500-8, Japan
Kagoshima , 892-0, Japan
Kobe , 650-0, Japan
Kumamoto , 860-0, Japan
Nagasaki , 852-8, Japan
Osaka , 534-0, Japan
Osaka , 543-8, Japan
Tokyo , 141-8, Japan
Busan , 48108, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 41944, Korea, Republic of
Daegu , 42415, Korea, Republic of
Daegu , 42472, Korea, Republic of
Hwasun , 58128, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 3080, Korea, Republic of
Seoul , 3722, Korea, Republic of
Seoul , 4401, Korea, Republic of
Seoul , 5030, Korea, Republic of
Seoul , 5505, Korea, Republic of
Seoul , 6351, Korea, Republic of
Seoul , 6591, Korea, Republic of
Seoul , 8308, Korea, Republic of
Sŏwŏn , 16499, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Kraków , 31-50, Poland
Słupsk , 76-20, Poland
Warszawa , 00-95, Poland
Warszawa , 50367, Poland
Coimbra , 3000-, Portugal
Lisboa , 11690, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Porto , 4200-, Portugal
Bucuresti , 20125, Romania
Bucuresti , 20125, Romania
Bucuresti , 20125, Romania
Bucuresti , 20125, Romania
Bucuresti , 22328, Romania
Cluj-Napoca , 40012, Romania
Craiova , 20014, Romania
Târgu-Mureş , 54004, Romania
Târgu-Mureş , 54013, Romania
Nizhny Novgorod , 60312, Russian Federation
Penza , 44007, Russian Federation
Petrozavodsk , 18501, Russian Federation
Ryazan' , 39003, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saratov , 41001, Russian Federation
St. Petersburg , 19102, Russian Federation
St. Petersburg , 19429, Russian Federation
Tula , 30005, Russian Federation
Belgrade , 11000, Serbia
Nis , 18000, Serbia
Novi Sad , 21101, Serbia
Singapore , 11907, Singapore
Singapore , 13854, Singapore
Palma Mallorca, 7014, Spain
Albacete , 2006, Spain
Alicante , 3010, Spain
Badalona , 8916, Spain
Barcelona , 8003, Spain
Barcelona , 8035, Spain
Barcelona , 8036, Spain
Barcelona , 8907, Spain
Bilbao , 48013, Spain
Cáceres , 10002, Spain
Córdoba , 14004, Spain
Girona , 17007, Spain
Granada , 18014, Spain
La Coruña , 15006, Spain
Las Palmas De Gran Canaria , 35010, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28223, Spain
Majadahonda , 28222, Spain
Málaga , 29010, Spain
Oviedo , 33011, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41013, Spain
Tarragona , 43005, Spain
Valencia , 46010, Spain
Valencia , 46017, Spain
Valencia , CP 46, Spain
Kaohsiung Niaosong District, 83301, Taiwan
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 33305, Taiwan
Cherkasy , 18009, Ukraine
Poltava , 36011, Ukraine
Vinnytsia , 21018, Ukraine
Zhytomyr , 10002, Ukraine
Maidstone , ME16 , United Kingdom
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