EUCTR2018-001588-22-IT进行中（未招募）1 期
Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (devimistat) in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (=50 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML) - ARMADA 2000
适应症
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
- •1. Males and females age = 50 years must have histologically documented AML that is relapsed from, or refractory to, prior standard therapies
- •2. Refractory is defined as failure to achieve CR or complete remission with incomplete recovery (CRi) following:
- •-Two standard dose Cytarabine based induction cycles or one High Dose Cytarabine (HiDAC) based cycle, or
- •-Persistent disease after one cycle of standard dose cytarabine (defined as no decrease in marrow blast percentage from diagnosis on Day 14 marrow) or
- •-Persistent disease after at least 2 cycles of a hypomethylating agent (azacytidine or decitabine) with or without venetoclax
- •3. Relapse is defined as development of recurrent AML (Döhner et al. 2017; 129[4]:424-447) after CR or CRi has been achieved with a prior chemotherapy or after disease progression on a hypomethylating agent with or without venetoclax
- •4. ECOG PS (performance score) 0-2
- •5. Expected survival greater than 3 months
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Patients who have received previous cytotoxic chemotherapy treatment for their relapsed or refractory AML. Previous treatment with hypomethylating agents (decitabine or azacytidine) either alone or in combination with Venetoclax is allowed. Targeted therapies including FLT3 or IDH1/2 inhibitors or Hydrea or venetoclax are allowed. Targeted therapies and Hydrea may be taken until the day prior to starting CHAM or HAM therapy
- •2. Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of CHAM or HAM therapy (the teratogenic potential of CPI-613® (devimistat) is unknown). Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at Screening
- •3. Patients receiving any other standard or investigational treatment for AML, or any other investigational agent for any indication within the past 1 week prior to initiation of CPI-613® (devimistat) treatment (the use of Hydrea and/or venetoclax, oral tyrosine kinase inhibitors FLT3 or IDH 1/2 inhibitors is allowed until the day prior to starting CHAM or HAM therapy). Previous exposure to a hypomethylating agent either alone or in combination with venetoclax is allowed.
- •4. Patients who have received immunotherapy of any type within the past 1 week prior to initiation of CPI-613® (devimistat) treatment.
- •5. Requirement for immediate palliative treatment of any kind including minor surgery
- •6. Patients who have received a chemotherapy regimen with autologous stem cell support (bone marrow transplantation) within 6 months of starting CHAM or HAM therapy.
- •7. Patients who have had allogenic bone marrow transplantation within the last 6 months. Patients who have had an allogenic transplant more than 6 months ago are eligible provided they have no graft vs host disease.
研究者
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