EUCTR2018-002851-14-ES进行中（未招募）1 期
A 2:1 randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type AM
FUNDACIÓN PETHEMA0 个研究点目标入组 281 人开始时间: 2019年6月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 281
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
入选标准
- •1.Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent before the first screening procedure. The patient and the investigator must sign informed consent form.
- •2.Diagnosis of untreated AML (according to the WHO 2008/2016 definition)
- •3.Age = 18 and =70 years old at the time of screening
- •4.Non-FLT3-ITD (allelic ratio <0.03) at diagnosis
- •5.Considered eligible to receive intensive chemotherapy as per investigator judgment
- •6.ECOG 0-2
- •7.No contraindications for quizartinib
- •8.The subject is receiving standard 7+3 induction chemotherapy regimen as specified in the protocol
- •9.No severe organ function abnormalities
- •10.Not included in other first-line trials
- •11.Cardiac ejection fraction = 45% assessed by echocardiography or MUGA.
- •12.Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception upon enrollment, during the treatment period and for 3 months following the last dose of investigational drug or cytarabine, whichever is later
- •13.Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later
- •14.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •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 281
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 281
排除标准
- •1.Patients with a genetic diagnosis of acute promyelocytic leukemia
- •2.Age <18 years or >70 years
- •3.ECOG performance status of 3 or 4
- •4.Prior treatment for AML, except for the following allowances:
- •a)Leukapheresis
- •b)Treatment for hyperleukocytosis with hydroxyurea
- •5.Blastic phase of bcr/abl chronic myeloid leukemia.
- •6.Presence of an associated active and/or uncontrolled malignancy: patients with another neoplastic disease, for whom the Investigator has a clinical suspicion of active disease at the time of enrollment. Note: Patients with adequately treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for this study. Hormonal or adjuvant therapies will be allowed for breast cancer or prostate cancer as long as they are on a stable dose for at least 2 weeks before the first dose.
- •7.Known active and not controlled hepatitis B or hepatitis C infection. In the event of a positive viral load, please consult with the Sponsor
- •8.Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study)
- •9.Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial
- •10.Serum creatinine = 250 µmol/l (= 2.5 mg/dL) (unless it is attributable to AML activity)
- •11.Bilirubin, alkaline phosphatase, or SGOT > 3 times the normal upper limit (unless it is attributable to AML activity)
- •12.Uncontrolled or significant cardiovascular disease, including any of the following:
- •a. Symptomatic bradycardia of fewer than 50 beats per minute, unless the subject has a pacemaker;
- •b. QTcF >450 msec at Screening. Note: QTcF will be derived from the mean of triplicate readings;
- •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 (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
- •f. History of a 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. An ejection fraction <45%
- •h. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening
- •i. History of New York Heart Association Class 3 or 4 heart failure
- •j. Right bundle branch and left anterior hemiblock (bifascicular block), complete left bundle branch block
- •13.History of hypersensitivity to any excipients in the quizartinib/placebo tablets
- •14.Females who are pregnant or breastfeeding
- •15.Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib.
- •16.Active acute or chronic GVHD requiring prednisone >10 mg or equivalent corticosteroid daily.
研究者
相似试验
进行中（未招募）
1 期
CIinical trial to compare the efficacy and safety of chemotherapy plus quizartinib versus chemotherapy plus placebo in patients with acute myeloid leukemia without FLT3 mutatioMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Acute myeloid leukemiaEUCTR2018-002851-14-PTFUNDACIÓN PETHEMA272
已完成
2 期
Chemotherapy with Camptothecin-11 (CPT-11), Fluorouracil (5FU), folinic acid and oxaliplatin in patients with metastatic colorectal cancerMetastatic Colorectal CancerCancer - Bowel - Back passage (rectum) or large bowel (colon)ACTRN12609000585224Hellenic Cooperative Oncology Group (HeCOG)314
招募中
2 期
A randomized controlled phase 2 trial comparing the safety and usefulness of robot-assisted esophagectomy and thoracoscopicJPRN-jRCT1040220153Takeuchi Hiroya90
尚未招募
2 期
A study to compare efficacy of cabazitaxel versus Docetaxel in recurrent head & neck cancerCTRI/2015/06/005848Tata Memorial Hospital92
未知
2 期
A phase II randomized study comparing the efficacy and safety of mFOLFOX6 + panitumumab combination therapy and 5-FU/LV + panitumumab combination therapy in the patients with chemotherapy-naive unresectable advanced recurrent colorectal carcinoma of KRAS wild-type after 6 cycles of combination therapy with mFOLFOX6 + panitumumabJPRN-jRCT1080222617TAKEDA PHARMACEUTICAL COMPANY LTD.164