EUCTR2014-002195-90-DK进行中（未招募）1 期
Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome (AML19) - AML19
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
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
- •They have one of the forms of CD33 positive (any level) favourable,
- •standard risk or unknown cytogenetics, de novo AML as defined by the
- •WHO Classification
- •WHO performance status 0-2.
- •They are considered suitable for intensive chemotherapy.
- •Age 16 to 60 years of age, with the following caveats: o Patients over
- •60 are eligible if intensive therapy is considered a suitable option o
- •Patients must be =18 to be eligible to receive Midostaurin
- •A negative pregnancy test within 2 weeks prior to trial entry in WOCBP
- •to be repeated throughout the trial prior to each course of protocol
- •Sexually mature males and females must agree to use an adequate and
- •medically accepted method of contraception throughout the study and
- •for 6 months following treatment (unless patient is female and received
- •Mylotarg- in which case it should be 7 months) if they or their sexual
- •partners are women of childbearing potential (WOCBP).
- •Written informed consent. · Patients must have Serum Alanine
- •Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =2.5
- •×ULN and bilirubin =2×ULN · For Midostaurin: Patients must have a FLT3
- •TKD or ITD mutation detected by the central laboratory in Cardiff
- •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 2900
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with APL, secondary AML, therapy-related AML, high risk
- •myelodysplastic syndrome with <20% bone marrow blasts, or de novo
- •AML with known adverse risk cytogenetics.
- •Concurrent active malignancy requiring treatment.
- •Patients who are pregnant or lactating.
- •Known infection with Human Immunodeficiency Virus (HIV).
- •Previous cytotoxic chemotherapy for AML. Note: Hydroxycarbamide, or
- •similar low-dose therapy, to control the white count prior to initiation of
- •intensive therapy is not an exclusion
- •Blast transformation of chronic myeloid leukaemia (CML).
- •The physician and patient consider that intensive therapy is not an
- •appropriate treatment option.
研究者
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