EUCTR2018-001588-22-AT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) therapy and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) 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:
- •a. At least one cycle of any anthracycline, cytarabine or fludarabine containing induction regimen or persistence of disease on a nadir marrow following at least one cycle of any anthracycline, cytarabine or fludarabine containing induction regimen
- •b. 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. Treatment with hypomethylating agents (decitabine or azacytidine) either alone or in combination with Venetoclax are allowed until the day prior to starting of CHAM or HAM therapy or control sub-groups (MEC and FLAG). Targeted therapies including FLT3 or IDH1/2 inhibitors and/or Hydrea and/or venetoclax are allowed. Targeted therapies and Hydrea may be taken until the day prior to starting of CHAM or HAM therapy or control sub-groups (MEC and FLAG).
- •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 or control sub-groups (MEC and FLAG) (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 are allowed until the day prior to starting CHAM or HAM therapy or control sub-groups (MEC and FLAG). Previous exposure to a hypomethylating agents either alone or in combination with venetoclax is allowed until the day prior to starting of CHAM or HAM therapy or control sub-groups (MEC and FLAG).
- •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 or control sub-groups (MEC and FLAG).
- •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.
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