EUCTR2015-004856-24-RO进行中（未招募）1 期
A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 536
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must be competent and able to comprehend, sign, and date an Ethics Committee or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
- •2. =18 years or the minimum legal adult age (whichever is gre
- •ater) and =75 years (at Screening);
- •3. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome, based on the World Health Organization (WHO) 2008 classification (at Screening);
- •4. Eastern Cooperative Oncology Group performance status 0-2 (at Screening);
- •5. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of =3% FLT3-ITD/total FLT3);
- •6. Subject is receiving standard 7+3 induction chemotherapy regimen as specified in the protocol;
- •7. Adequate renal function defined as:
- •a. Serum creatinine =1.5 × the upper limit of normal (ULN); or
- •b. Glomerular filtration rate >50 mL/min/1.73m2, as calculated with the modified Cockcroft Gault equation;
- •8. Adequate hepatic function defined as:
- •a.Total serum bilirubin =1.5 × ULN;
- •b.Serum alkaline phosphatase, aspartate transaminase and alanine transaminase =2.5 × ULN;
- •9. Serum electrolytes (potassium, calcium, and magnesium) within normal limits. If outside of normal limits, subject will be eligible when electrolytes are corrected;
- •10. If female, must be either postmenopausal (no menstrual period for a minimum of 12 months), surgically sterile, or if of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use maximally effective double-barrier birth control during the period of therapy and contraception for 3 months following the last investigational drug dose;
- •11. If male, must be surgically sterile or willing to use an effective double-barrier contraception method upon enrollment, during the course of the study, and for 3 months following the last investigational drug dose.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 268
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 268
排除标准
- •1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis);
- •2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;
- •3. Prior treatment for AML, except for the following allowances:
- •a. Leukapheresis;
- •b. Treatment for hyperleukocytosis with hydroxyurea;
- •c. Cranial radiotherapy for central nervous system (CNS) leukostasis;
- •d. Prophylactic intrathecal chemotherapy;
- •e. Growth factor/cytokine support;
- •4. Prior treatment with quizartinib or other FLT3-ITD inhibitors;
- •5. Prior treatment with any investigational drug or device within 30 days prior to Randomization or who are currently participating in other investigational procedures;
- •6. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for subjects with symptoms of CNS leukemia to rule out extramedullary CNS involvement;
- •7. 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;
- •8. Uncontrolled or significant cardiovascular disease, including any of the following:
- •a. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
- •b. QTcF interval >450 msec;
- •c. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
- •d. Systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg;
- •e. History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
- •f. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
- •g. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
- •h. History of New York Heart Association Class 3 or 4 heart failure;
- •i. Known history of left ventricular ejection fraction (LVEF) =45% or less than the institutional lower limit of normal;
- •j. History of complete left or complete right bundle branch block;
- •9. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
- •10. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C)
- •11. Known history of human immunodeficiency virus (HIV). Subjects should be tested for HIV prior to randomization if required by local regulations or EC;
- •12. History of hypersensitivity to any excipients in the quizartinib/placebo tablets;
- •13. Females who are pregnant or breastfeeding;
- •14. Otherwise considered inappropriate for the study by the investigator.
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