EUCTR2008-006931-11-NL进行中（未招募）不适用
A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
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
- •1. Patients must have a documented diagnosis of one of the following
- •MLL-rearranged ALL, refractory to standard induction treatment or in
- •first or subsequent relapse
- •FLT3-mutated AML refractory to standard induction (after failure of at
- •least 2 different induction chemotherapy regimens) or refractory to reinduction
- •at 1st relapse (after failure of the first re-induction course), or
- •in second or greater relapse
- •2. Patients must be less than 18 years of age and =3 months of age.
- •3. Patients must have a Lansky/Karnofsky performance status = 60.
- •4. Patients must have the following laboratory values reflecting appropriate
- •organ function:
- •AST and ALT = 5x Upper Limit of Normal (ULN),
- •Serum Bilirubin = 1.5 x ULN,
- •Serum Creatinine = 2 x ULN.
- •5. Patients must have an expected survival of greater than 8 weeks.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with symptomatic leukemic CNS involvement.
- •2. Patients with isolated extramedullary leukemia.
- •3. Patients must have recovered from prior cytotoxic chemotherapy, and a
- •minimum wash-out time of previous chemotherapy of 72 hours should be
- •taken into account.
- •4. Patients who had prior allogeneic, syngeneic or autologous bone marrow
- •or stem cell transplant less than 2 months from Day 1
- •5. Patients who have received any investigational agent within 30 days or 5
- •half lives, whichever is greater, prior to Day 1. An investigational agent is
- •an agent with no approved medical uses in adults or pediatrics.
- •6. Patients who have had prior treatment with a FLT3 inhibiting drug or
- •investigational agent.
- •7. Use of CYP3A4/5 enzyme inducing or inhibiting drugs or herbal
- •supplements while on study treatment
- •8. The use of corticosteroids while on study drug
- •9. Patients who have had any surgical procedure, excluding central venous
- •catheter placement or other minor procedures (e.g. skin or bone marrow
- •biopsy), within 14 days of Day 1.
- •10. Patients with any other known disease concurrent severe and/or
- •uncontrolled medical condition (e.g. cardiovascular disease including
- •congestive heart failure or active uncontrolled infection) which could
- •compromise participation in the study.
- •11. Patients with an abnormal chest X-ray and/or any pulmonary infiltrate
- •including those suspected to be of infectious origin. In particular, patients
- •with resolution of clinical symptoms of pulmonary infection but with
- •residual pulmonary infiltrates on chest x-ray are not eligible until
- •pulmonary infiltrates have completely resolved.
- •12. Patients with known impairment of gastrointestinal (GI) function or GI
- •disease that may significantly alter the absorption of midostaurin,
- •including active graft-versus-host disease of the liver or the gut.
- •13. Patients with a known confirmed diagnosis of HIV infection or active viral
- •14. Patients with a left ventricular shortening fraction < 27% as determined by
- •MUGA scan or echocardiogram
- •15. Patients with abnormal ECG including:
- •QTcF = 450 ms, PR =200 msec, QRS complex =110 msec, at
- •Any cardiac conduction abnormality
- •Any morphologic abnormality
- •Any ST/T wave abnormality
- •Any atrial or ventricular arrhythmia
- •16. Female patients who are pregnant or breast feeding or patients of
- •reproductive potential not employing an effective method of birth control.
- •Barrier contraceptives must be used throughout the trial by both sexes, if
- •applicable.
- •17. Males of reproductive potential unwilling to comply with contraceptive
- •requirements
- •18. Patients/parents unwilling or unable to comply with the protocol
研究者
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