NL-OMON52604招募中2 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 Continuation 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 - AC220-A-U202
Daiichi Pharmaceutical0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
入选标准
- •1. Diagnosis of AML according to the World Health Organization (WHO) 2008
- •classification with >=5% blasts in bone marrow, with or without extramedullary
- •2. Subjects must be in first relapse or refractory to first-line high-dose
- •chemotherapy with no more than 1 attempt (1 to 2 cycles of induction
- •chemotherapy) at remission induction. Prior HSCT is permitted.
- •3. Presence of the FLT3-ITD activating mutation in bone marrow or peripheral
- •blood that is confirmed by central testing. The results of FLT3 ITD testing
- •must be obtained prior to the first dose of quizartinib (Re-Induction Cycle 1,
- •Day 6). Subjects may be enrolled and begin treatment with the systemic
- •protocol therapy pending the result of the FLT3 ITD testing; however, subjects
- •with a negative central and local FLT3 ITD test who are enrolled and have begun
- •systemic protocol treatment will be discontinued from the study. Subjects may
- •also 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 R/R disease);
- •however, a sample must be sent to the central laboratory for confirmation.
- •Subjects with a negative central FLT3-ITD test who are enrolled and have begun
- •treatment based upon results of a FLT3-ITD test conducted at a local laboratory
- •may continue on the study at the investigator*s discretion after discussion
- •with the medical monitor.
- •4. Subjects must be between 1 month and <=21 years of age at the time the ICF is
- •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 clinically significant
- •toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy
- •prior to Re-Induction Cycle 1, Day 1:
- •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 1 day prior to the start of systemic protocol therapy.
- •Subjects may also receive
- •low dose cytarabine (100 mg/m2/dose once daily for up to 5 days) for
- •cytoreduction and completed up to 1 day prior to the start of systemic protocol
- •* Subjects who have received other FLT3 inhibitors (eg,
- •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
- •(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
- •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. For subjects with a
- •history of graft versus host disease (GVHD), immunosuppressive therapy must be
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), French-American-British (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 ms:
- •* QTc interval corrected with Bazett*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 beats/minute on screeening electrocardiogram (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 prior to the start of systemic protocol therapy..
- •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
- •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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