EUCTR2016-002919-18-ES进行中（未招募）1 期
A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Maintenance Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD mutations.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •Subjects must satisfy all of the following inclusion criteria prior to enrollment:
- •1. Diagnosis of AML according to the World Health Organization (WHO) 2008 classification with >5% blasts in bone marrow, with or without extramedullary disease.
- •2. Subjects must be in first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1-2 cycles of induction chemotherapy) at remission induction.
- •3. Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as confirmed by the central laboratory =3% FLT3-ITD/total FLT3). Subjects may be enrolled and begin treatment based upon the results of a local FLT3-ITD laboratory test (performed on or after the date of diagnosis of relapse/refractory disease), however, a sample must be sent to the central laboratory for confirmation.
- •4. Subjects must be between 1 month and =21 years of age at the time the Informed Consent/Assent form is signed.
- •5. Karnofsky performance status score of >50% for subjects >16 years of age, and a Lansky performance status score of >50% for subjects =16 years of age.
- •6. Subjects must have fully recovered from the acute toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study:
- •a. Myelosuppressive chemotherapy:
- •- For subjects who relapse while they are receiving cytotoxic therapy, at least 21 days must have elapsed since the completion of cytotoxic therapy.
- •- Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of systemic protocol therapy. Subjects may also receive low dose cytarabine (100 mg/m2/dose once daily for 5 days) for cytoreduction.
- •- Subjects who have received other FLT3 inhibitors (e.g., lestaurtinib, sorafenib), with the exception of quizartinib, are eligible for this study.
- •b. Hematopoietic growth factors: At least 3 days since the completion of therapy with a growth factor.
- •c. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. However, for agents that have known adverse events (AEs) occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the medical monitor.
- •d. =14 days for local external radiation therapy (XRT) for CNS chloromas.
- •e. =90 days must have elapsed if prior total body radiation (TBI) or craniospinal XRT occurred.
- •f. At least 90 days must have elapsed since HSCT; and subjects must not have active graft-versus-host disease (GVHD). Immunosuppressive therapy must be stable for =2 weeks in subjects with a history of = Grade 2 GVHD and for =4 weeks in subjects with a history of Grade 3/4 GVHD.
- •g. Investigational Drug/Device: at least 30 days or 5 half-lives since the completion of therapy, whichever is longer.
- •7. Adequate renal and hepatic functions as indicated by the following laboratory values:
- •a. Serum creatinine concentration = institutional upper limit of nor al (ULN) based on the age and gender.
- •b. Total bilirubin <1.5 x ULN for age or normal conjugated bilirubin (unless related to leukemic involvement).
- •c. Alanine transaminase (ALT) <5 × ULN (unless related to leukemic involvement).
- •8. LV fractional shortening of =29% by echocardiogram, OR a left ventricular ejection fraction of =50% by radionuclide angiogram.
- •9. Female subjects of childbearing potential must have a negative urine or serum pregnancy test confirmed w
排除标准
- •Subjects who meet any of the following criteria will be disqualified from entering the study:
- •1. Diagnosis of isolated CNS relapse (CNS2/3 disease is allowed if treated with additional IT chemotherapy).
- •2. Diagnosis of acute promyelocytic leukemia (APL), Juvenile myelomonocytic leukemia (JMML), FAB classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or myeloid proliferations related to Down syndrome.
- •3. Uncontrolled or significant cardiovascular disease, including:
- •a. Diagnosed or suspected congenital long QT syndrome.
- •b. History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes [TdP]); any history of arrhythmia will be discussed with the Medical Monitor prior to subject’s entry into the study.
- •c. QT interval corrected >450 msec:
- •QTc interval corrected with Bazzet’s formula (QTcB) for subjects < 6 years of age at the time of enrollment.
- •QTc interval corrected with Fridericia’s formula (QTcF) for subjects = 6 years of age at the time of enrollment.
- •d. History of uncontrolled angina pectoris or myocardial infarction within 6 months.
- •e. 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).
- •f. Heart rate <50/minute on pre-entry ECG.
- •g. Uncontrolled hypertension (i.e., systolic blood pressure and /or diastolic blood pressure that is, on repeated measurement, at or above the 95th percentile for sex, age, and height).
- •h. History of complete left bundle branch block.
- •i. History of New York Heart Association Class 3 or 4 heart failure.
- •4. Subjects will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The subject needs to be off vasopressors and have negative blood cultures for at least 48 hours.
- •5. Known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C).
- •6. Known history of human immunodeficiency virus (HIV).
- •7. History of hypersensitivity to any of the study medications or their excipients.
- •8. Subject is receiving or is anticipated to receive concomitant chemotherapy, radiation, or immunotherapy other than as specified in the protocol.
- •9. Any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise subject safety or compliance, interfere with consent/assent, study participation, follow up, or interpretation of study results.
- •10. Currently participating in other investigational interventional procedures (does not include observational procedures or long-term follow-up for previous interventional studies).
- •11. Otherwise considered inappropriate for the study by the Investigator.
研究者
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