EUCTR2017-002094-18-IT进行中（未招募）1 期
Prospective evaluation of a continuation therapy with Midostaurin in adult patients withcore-binding factor leukemia and integrated genetic analysis: a multi-center phase II study - Prospective evaluation of a continuation therapy with Midostaurin in adult patients with core-bindin
AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA0 个研究点目标入组 39 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1. Written informed consent must be obtained prior to any screening procedures.
- •2. Patients must be 18 to 65 years of age at the time of signing informed consent.
- •3. Patients must have an unequivocal diagnosis of de novo-CBFL, prior to start Midostaurin,
- •documented by rearrangement of Core Binding Factor (CBF) genes, namely AML1-ETO and CBFBMYH11,
- •either with observation of t(8;21)(q22;q22) or inv(16)(p13; q32)/t(16;16)(p13; q32) by
- •conventional cytogenetics or hybridization techniques or detection of fusion genes by PCR
- •4. Patients must be fit to receive an anthracyclin/AraC-based induction therapy (i.e. Ara-C 100
- •mg/m2 or 200 mg/m2 i.v. day, by continuous infusion for 7 days and Idarubicin 12 mg/m2 i.v. day or
- •daunomycin 60 mg/m2 on days 1, 3 and 5)
- •5. Patients must have an ECOG Performance Status of = 2.
- •6. Patients must have Total Bilirubin = 1.5 x ULN, and AST or ALT = 2.5 x ULN.
- •7. Patients must have Serum Creatinine = 1.5 x ULN.
- •8. Women of child-bearing potential must have a negative pregnancy test before starting the
- •Are the trial subjects under 18? no
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1. Prior therapy for AML with the following exceptions:
- •a. emergency leukapheresis
- •b. emergency treatment for hyperleukocytosis with hydroxyurea for = 7 days
- •2. Central nervous system involvement
- •3. Presence of any uncontrolled bacterial, viral or fungal infection
- •4. Known human immunodeficiency virus (HIV) positive
- •5. An active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Patients whose disease is
- •controlled under antiviral therapy should not be excluded.
- •6. Presence of other active malignancies
- •7. QTc > 470 msec (Bazett formula) on screening ECG
- •8. Presence of significant uncontrolled or active cardiovascular disease, specifically including,
- •but not restricted to:
- •a. Myocardial infarction, unstable angina and/or congestive heart failure within 3 months prior to
- •randomization
- •b. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any
- •ventricular arrhythmia
- •c. Uncontrolled hypertension
- •d. Taking medications that are known to be associated with Torsades de Pointes.
- •9. History of hypersensitivity to any drugs or metabolites of similar chemical classes as the study
- •10. 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.
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