ISRCTN12632431进行中（未招募）3 期
A prospective randomized, double-blind, placebo-controlled, multi-center Phase III study to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia patients undergoing allogeneic hematopoietic cell transplantation
Priothera S.A.S.0 个研究点目标入组 249 人开始时间: 2023年6月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 249
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
- 性别
- All
入选标准
- •Current inclusion criteria:
- •1. Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 2022 classification of AML and related precursor neoplasms, including AML with myelodysplasia-related gene mutations.
- •2. Subjects with European LeukemiaNet (ELN) high-risk or intermediate-risk AML in CR1, intermediate-risk AML in CR1, or AML of any risk in CR2. (Complete remission with incomplete count recovery [CRi] is also allowable).
- •3. Subjects planned to undergo allogeneic HCT
- •4. Life expectancy =6 months at screening
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Male or female, age =18 years and =75 years
- •Previous inclusion criteria:
- •1. Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 2016 classification of AML and related precursor neoplasms, including secondary AML after an antecedent hematological disease (e.g. myelodysplastic syndrome) and therapy-related AML
- •2. Subjects with European LeukemiaNet (ELN) high risk AML in CR1, intermediate-risk AML in CR1 if MRDpos, or AML of any risk in CR2. Complete remission is defined as: <5% marrow blasts by morphologic examination and no circulating peripheral blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count =1.0 x 10e9/L (1000/µl); platelet count =100 x 10e9/L (100 000/µl)
- •3. Subjects planned to undergo allogeneic HSCT
- •4. Life expectancy =6 months at screening
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Male or female, age =18 years and =75 years
排除标准
- •Current exclusion criteria as of 19/07/2024:
- •1. Planned use of anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
- •2. Planned use of serotherapy during conditioning, including ATG and alemtuzumab
- •3. Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection
- •4. Subjects having received prior allogeneic HCT or recipients of a solid organ transplant
- •5. Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (> 10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible.
- •6. Require treatments for cardiac dysfunction
- •7. Subjects with acute promyelocytic leukemia
- •8. Blast crisis of chronic myeloid leukemia
- •9. Cardiac dysfunction
- •10. Pulmonary dysfunction
- •11. Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); or total bilirubin >1.5 x ULN
- •12. Renal dysfunction with creatinine clearance <45 ml/min by the Cockcroft-Gault formula
- •13. History of stroke or intracranial hemorrhage within 1 year prior to screening
- •14. Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HCT
- •Previous exclusion criteria:
- •1. Planned use of anti-thymocyte globulin (ATG), post-transplantation cyclophosphamide, sirolimus, mycophenolate mofetil, abatacept, or any approved or non-approved medication other than MTX plus CsA or MTX plus TAC for GVHD prophylaxis
- •2. Planned use of serotherapy during conditioning, including ATG and alemtuzumab
- •3. Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection
- •4. Subjects having received prior allogeneic HSCT or recipients of a solid organ transplant
- •5. Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (>10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible.
- •6. Require treatments for cardiac dysfunction
- •7. Subjects with acute promyelocytic leukemia
- •8. Blast crisis of chronic myeloid leukemia
- •9. Cardiac dysfunction
- •10. Pulmonary dysfunction
- •11. Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); or total bilirubin >1.5 x ULN
- •12. Renal dysfunction with creatinine clearance <60 ml/min by the Cockcroft-Gault formula
- •13. History of stroke or intracranial hemorrhage within 1 year prior to screening
- •14. Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HSCT
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