EUCTR2016-004440-12-IT进行中（未招募）1 期
An open-label, multi–center, Phase IIIb study to assess the safety and efficacy of midostaurin (PKC412) in patients 18 years of age or older withnewly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) who are eligible for 7+3 or 5+2 chemotherapy -
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Written informed consent must be obtained prior to any screening procedures.
- •2. Patients must be 18 years of age or older at the time of signing informed consent.
- •3. Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification. A bone marrow or blood blast
- •count of =20% is required, except for AML with t(15;17), t(8;21), inv(16) or t(16;16)) where blast count may be <20%, and excluding M3
- •(acute promyelocytic leukemia).
- •4. Patients with secondary AML are eligible, e.g. patients with antecedent history of treatment for prior malignancy. AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30
- •days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
- •5. Patients must have started 7+3 or 5+2 first induction chemotherapy regimen.
- •6. Patients must have a documented FLT3 mutation (ITD or TKD).
- •7. Patients must have an ECOG Performance Status of = 2
- •8. Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
- •9. Patients must have Total Bilirubin = 2.5 x ULN.
- •10. Patients must have Serum Creatinine = 2.5 x ULN.
- •11. Patients must be able to communicate well with the investigator to understand and comply with the requirements of the study.
- •12. Women of child-bearing potential must have a negative pregnancy test before starting use of midostaurin.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Prior therapy for AML with the following exceptions:
- •a. emergency leukapheresis
- •b. emergency treatment for hyperleukocytosis with hydroxyurea for = 7
- •c. cranial RT for CNS leukocytosis (one dose only)
- •d. growth factor/cytokine support
- •2. Patients with Left Ventricular Ejection Fraction (LVEF) less than 45%
- •(by echocardiogram or MUGA) or symptomatic congestive heart failure
- •(Class III or IV) according to New York Heart Association (NYHA)
- •classification
- •3. Patients with any pulmonary infiltrate including those suspected to be
- •of infectious origin (unless resolved to < Grade 1 within screening
- •4. Patients with any uncontrolled illness, including, but not limited to,
- •acute or chronic pancreatitis or uncontrolled infection
- •5. QTc >470 msec on screening ECG.
- •6. History of hypersensitivity to any drugs or metabolites of similar
- •chemical classes as the study treatment.
- •7. Participation in a prior investigational interventional (drug) study with
- •administration of the investigational product within 30 days or 5 halflives
- •of the investigational product, whichever is longer.
- •8. Pregnancy statements and contraception requirements:
- •Women of child-bearing potential, defined as all women physiologically
- •capable of becoming pregnant, unless they are using highly effective
- •methods of contraception during dosing and for at least 4 months after
- •stopping medication. Highly effective contraception methods include:
- •Total abstinence (when this is in line with the preferred and usual
- •lifestyle of the subject). Periodic abstinence (e.g. calendar, ovulation,
- •symptothermal, post-ovulation methods) and withdrawal are not
- •acceptable methods of contraception
- •Female sterilization (have had surgical bilateral oophorectomy with or
- •without hysterectomy), total hysterectomy, or tubal ligation at least six
- •weeks before taking study treatment. In case of oophorectomy alone,
- •only when the reproductive status of the woman has been confirmed by
- •follow up hormone level assessment
- •Male sterilization (at least 6 months prior to screening). The
- •vasectomized male partner should be the sole partner for that subject.
- •Use of oral, injected or implanted hormonal methods of contraception
- •or placement of an intrauterine device or intrauterine system , or other
- •forms of hormonal contraception that have comparable efficacy (failure
- •rate <1%), for example hormone vaginal ring or transdermal hormone
- •contraception.
- •In case of use of oral contraception women should also add a barrier
- •method of contraception, particularly as it is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives.
- •Sexually-active males unless they use a condom during intercourse with
- •females of reproductive potential or pregnant women and for at least 4
- •months after stopping treatment to avoid conception or embryo-fetal
- •9. Patients enrolled in this study are not permitted to participate in
- •additional parallel study drug or device studies.
研究者
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