EUCTR2019-001976-12-ES进行中（未招募）1 期
A multicenter, prospective, non-randomized, Phase I-II trial to assess the efficacy and safety of the combination of oral quizartinib and the FLAG-IDA chemotherapy regimen in first relapsed/refractory acute myeloid leukemia (R/R AML) patients
Fundación Pethema0 个研究点目标入组 92 人开始时间: 2019年7月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
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 prior to the first screening procedure. Informed consent form must be signed by the patient and the Investigator.
- •2. Patients aged 18 to 70 years old at the time of screening.
- •3. First R/R AML defined as:
- •First relapse after frontline intensive chemotherapy (with or without prior alloSCT), irrespectively of the duration of the first CR. Patients previously treated with a FLT3 inhibitor different from quizartinib, can be included.
- •First refractory disease (defined as patients not achieving at least a PR after first induction cycle and/or not achieving CR/CRi after first 2 cycles). Patients previously treated with a FLT3 inhibitor different from quizartinib, can be included.
- •4. Non-APL AML.
- •5. Considered for intensive approach as per Investigator judgment.
- •6. ECOG 0-2.
- •7. No contraindications for quizartinib.
- •8. No contraindications for intensive chemotherapy.
- •9. No severe organ function abnormalities.
- •10. No active relevant GVHD.
- •11. For the Phase II, FLT3-ITD patients will represent 50% of the study cohort (FLT3-TKD are not excluded but included in the FLT3-ITD-WT group).
- •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 6 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 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients with genetic diagnosis of acute promyelocytic leukemia.
- •2. Blastic phase of bcr/abl chronic myeloid leukemia.
- •3. Patients with other neoplastic disease, for whom the Investigator has 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 if they are on a stable dose for at least 2 weeks prior to first dose.
- •4. Presence of any severe psychiatric disease or physical condition/comorbidity that, according to the physician´s criteria, contraindicates the inclusion of the patient in the clinical trial
- •5. Serum creatinine > or = 250 µmol/l (> or = 2.5 mg/dL) (unless it is attributable to AML activity).
- •6. Bilirubin, alkaline phosphatase, or SGOT >3 times the upper normal limit (unless it is attributable to AML activity).
- •7. Uncontrolled or significant cardiovascular disease, including any of the following:
- •- Symptomatic bradycardia of less than 50 beats per minute, unless the subject has a pacemaker.
- •- QTcF >450 ms at screening. Note: QTcF will be derived from the mean of triplicate readings.
- •- Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome)
- •- History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes).
- •- 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).
- •- History of uncontrolled angina pectoris or myocardial infarction within 6months prior to Screening.
- •- History of New York Heart Association Class 3 or 4 heart failure.
- •- Complete left bundle branch block.
- •- Right bundle branch and left anterior hemiblock (bifascicular block)
- •- Infarction (MI) within 3 months.
- •- Systolic blood pressure > or = 180 mmHg or diastolic blood pressure > o =110 mmHg
- •- A previously known left ventricle ejection fraction <45%
- •8. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
- •9. Active hepatitis B or hepatitis C infection.
- •10. Previously known and documented human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study).
- •11. Active acute or chronic GVHD requiring prednisone >10 mg or equivalent corticosteroid daily
- •12. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib
- •13. History of hypersensitivity to any excipients in the quizartinib tablets.
- •14. Females who are pregnant or breastfeeding.
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