ACTRN12621000439842招募中未知
AMLM26- INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial - The Master Protocol
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •for study entry:
- •- diagnosis of AML in first or second CR/CRi
- •- a diagnostic baseline bone marrow and/or blood sample suitable for DNA/RNA-based studies is available
- •- presence of molecular and/or flow cytometric MRD marker(s) at AML diagnosis
- •to commence active treatment:
- •- WBC <25 x 10^9/L (hydroxyurea permitted for WCC control)
- •- for initial therapy on trial patient must have evidence of morphologic relapse or molecular progression/relapse
- •- for patients on trial rotating to other therapies - must have evidence of progressive disease, treatment failure or relapse
- •there will be additional arm specific eligibility criteria which will be specified in the domain-specific protocols
排除标准
- •for study entry:
- •-Acute promyelocytic leukaemia
- •-prior allogeneic stem cell transplantation within 3 months of post-conditioning or on greater than or equal to 10mg/day prednisolone for graft vs host disease
- •to commence active treatment:
- •- known active CNS disease
- •-Within 14-days from receipt of prior anti-leukaemic therapy (except hydroxyurea or 6-thioguanine)
- •there will be additional arm specific eligibility criteria which will be specified in the domain-specific protocols
研究者
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