EUCTR2006-006852-37-CZ进行中（未招募）1 期
A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy + midostaurin (PKC 412) (IND # 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML) - PKC412A2301
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
- 500
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
- •Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
- •Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designed FLT3 screening laboratory.
- •Age greater than or equal to 18 years.
- •Age less than 60 years.
- •AML patients with a history of antecedent myelodyspasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g. azacitidine or decitabine).
- •Bilirubin < 2.5 times upper limit of normal.
- •Women of childbearing potential must have a negative serum or urine pregnancy test within a sensitivity of at least 50 mIU/ml within 16 days prior to registration and must either commit to continued abstinence from heterosexual intercourse or commit to two acceptable methods of birth control (one highly effective and one additional effective method) at the same time. This should be commenced before receiving midostaurin/placebo therapy and continue for 12 weeks after completion of all midostaurin therapy.
- •Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking midostaurin/placebo and for 12 weeks after therapy is stopped, even if they have undergone a successful vasectomy.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:
- •- emergency leukapheresis
- •- emergency treatment for hyperleukocytosis with hydroxyurea for less than or equal to 5 days
- •- cranial RT for CNS leukostasis (one dose only)
- •- growth factor/cytokine support
- •Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible.
- •Patients with symptomatic congestive heart failure are not eligible.
- •Pregnant or nursing patients may not be enrolled.
研究者
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