NL-OMON32771招募中3 期
A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy + Midostaurin (PKC412) (IND# 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated Acute Myeloid Leukemia (AML) - CALGB 10603 / PKC412 / FLT3 AM
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 and 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.
排除标准
- •*No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:
- •i. emergency leukapheresis
- •ii. emergency treatment for hyperleukocytosis with hydroxyurea for less than or equal to 5 days
- •iii. cranial RT for CNS leukostasis (one dose only)
- •iv. 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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