EUCTR2016-002919-18-IT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 QuizartinibAdministered in Combination with Re-Induction Chemotherapy, and as aSingle-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AMLSubjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD mutations. - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
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
- •- 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.
- •Please refer to the protocol for a complete description of inclusion criteria.
- •Are the trial subjects under 18? yes
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •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.
- •Please refer to the protocol for a complete description of exclusion criteria.
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