NL-OMON53485尚未招募2 期
CHIP-AML22/Quizartinib: A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild type AML patients. (A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium) - CHIP-AML22/Quizartinib
Prinses Máxima Centrum voor Kinderoncologie0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
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) Enrollment on CHIP-AML22/Master:
- •Patients must be enrolled on the CHIP-AML22/Master prior to enrolment on
- •CHIP-AML/Quizartinib linked-trial, and may have received a diagnostic work-up
- •according to the master protocol. Induction treatment can be started as
- •standard of care.
- •2) FLT3-ITD+ and wild-type NPM1:
- •Presence of FLT3-ITD+ and NPM1 wild type in bone marrow or peripheral blood
- •provided by the local laboratories, as part of standard of care diagnostics.
- •The results of FLT3-ITD testing must be obtained prior to the first dose of
- •quizartinib (e.g., Induction course 1, Day 10).
- •Patients must be from 1 month to <= 18 years old at initial diagnosis
- •4) Performance status
- •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.
- •5) Organ function criteria:
- •These criteria must be met based on the results before start of any
- •chemotherapy (e.g., MEC)
- •a. Adequate Renal Function Defined as:
- •Calculated eGFR >= 50 mL/min/1.73 m2 using the Schwartz formula.
- •b. Adequate Liver Function Defined as:
- •Total or direct (conjugated) bilirubin < 5xULN for age (<= 5xULN if related to
- •involvement), AND
- •Aspartate transaminase (AST) and alanine transaminase (ALT) <5xULN (<10×ULN if
- •related to leukemic involvement)
- •6) Life expectancy: > 6 weeks
- •7) Pregnancy test:
- •Serum/urine pregnancy test (for all girls >= age of menarche) negative within 2
- •weeks prior to enrollment on the quizartinib linked-trial.
- •8) Taking quizartinib:
- •Patients must be able to reliably swallow or administer quizartinib by NG tube.
- •9) Informed consent:
- •Written informed consent/assent for the quizartinib linked trial from patients
- •and/or from parents or legal guardians for minor patients, according to local
- •law and regulations.
排除标准
- •General exclusion criteria
- •a. Patients with only extramedullary disease
- •b. Uncontrolled or significant cardiovascular disease, including
- •i. Diagnosed or suspected congenital long QT syndrome
- •ii. History of clinically significant ventricular arrhythmias (such as
- •ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes); any
- •history of arrhythmia will be discussed with sponsor, the national coordinator
- •and C.I. the prior to subject*s entry into the study.
- •iii. QT interval corrected >450 ms:
- •- QTc interval corrected with Fridericia*s formula (QTcF) for subjects >= 6
- •years of age at the time of enrollment.
- •iv. Left ventricular systolic dysfunction (LVSD), defined as ejection fraction
- •(EF) below 55% during the screening for the CHIP-AML22/Master protocol.
- •v. History of uncontrolled angina pectoris or myocardial infarction within 6
- •vi. 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).
- •vii. Heart rate <50 beats/minute on ECG during the screening for the
- •CHIP-AML22/Master protocol (In case, adolescents with a normal sinusoidal
- •rhythm and no evidence of other cardiac dysfunction will be discussed with
- •sponsor, the national coordinator and C.I. the prior to subject*s entry into
- •the study.)
- •viii. Uncontrolled hypertension (e.g., systolic blood pressure and /or
- •diastolic blood pressure that is, on repeated measurement, at or above the 95th
- •percentile for sex, age, and height).
- •ix. History of complete left bundle branch block.
- •x. History of New York Heart Association Class 3 or 4 heart failure.
- •c. Known history of HIV or active clinically relevant liver disease (e.g.,
- •active hepatitis B or active hepatitis C)
- •d. Underlying GI disease that may affect absorption of study drug
- •e. Use of strong or moderate CYP3A inducers will be prohibited throughout the
- •duration of the study. Strong CYP3A4 inhibitors will be allowed with a
- •concomitant dose reduction of quizartinib with the exception during the safety
- •f. History of hypersensitivity to any of the study medications or their
- •excipients.
- •g. Other serious illnesses or medical conditions, that will likely make it
- •impossible to complete treatment according to protocol (e.g., patients who
- •should not be given any of the study medications based on the SmPC)
- •h. Currently participating in other investigational interventional procedures,
- •if it interferes with any endpoints of the quizartinib trial.
- •Note: Patients may be enrolled in either SCRIPT-AML or Pro-Teico study (i.e.,
- •conditioning regimen for allo-SCT or infection prophylaxis) as
- •a) The endpoints of the quizartinib trials are not influenced
- •b) These trials are evaluating approved agents
- •c) The medications being evaluated do not conflict with the mechanism of action
- •of quizartinib
- •2) Additional exclusion criteria during safety run-in
- •a. Patients with CNS3 disease
- •b. Using strong CYP3A4 inhibitors (If patient can stop using strong CYP3A4
- •inhibitors, he/she will be allowed to enroll. In such case, no washout is
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