CTIS2022-500295-60-00招募中1 期
An ALFA 2101 multicenter randomized phase II study: CPX-351 versus intensive chemotherapy in patients with de novo intermediate or adverse risk AML stratified by genomics - 21-PP-26
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 210
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 65+（—）
- 性别
- All
入选标准
- •De novo AML, No MRC-defining cytogenetic lesion, No t(15;17), t(8;21), inv(16) or t(16;16), No NPM1 gene mutation, No FLT3 mutated AML (FLT3 ITD or TKD), Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms,, Age above or equal to 50 years, Performance status below or equal to 2 (ECOG grading),
排除标准
- •Prior history of documented MDS, MPN or MDS/MPN, tAML, Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer), Patient has active and uncontrolled infection., Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance., Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.
研究者
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