EUCTR2015-004856-24-IT进行中（未招募）1 期
A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination with Induction and ConsolidationChemotherapy, and Administered as Continuation Therapy in Subjects 18 to75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First) -
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 greater) and =75 years (at
- •Screening);
- •3.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);
- •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
- •6.Subject is receiving standard 7+3 induction chemotherapy regimen as specified in the protocol;
- •7.Adequate renal function defined as: a. Creatinine clearance rate >50 mL/min, 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 within normal limits: potassium, calcium (total or corrected for serum albumin in case of hypoalbuminemia) and magnesium. If outside of normal limits, subject will be eligible when electrolytes are corrected;
- •10.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) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy
- •or bilateral oophorectomy);
- •11.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.
- •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); subjects 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).
- •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
- •(within 2 weeks for investigational or approved immunotherapy) or 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 nonmelanoma
- •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
- •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
- •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.Complete left 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;
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