EUCTR2021-002864-36-DE进行中（未招募）1 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 in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT)
Priothera S.A.S.0 个研究点目标入组 249 人开始时间: 2022年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 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
- •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 therapy
- •AML with myelodysplasia related gene mutations.
- •2.Subjects with European LeukemiaNet (ELN) high risk or intermediate
- •risk or AML in CR1, or AML of any risk in CR2. (Complete remission with
- •incomplete count recovery [CRi] is also allowable).
- •- Complete remission is defined as: < 5% marrow blasts by morphologic
- •examination and no circulating peripheral blasts ; absence of
- •extramedullary disease; absolute neutrophil count = 1.0x109/L
- •(1000/µL); platelet count = 100x109/L (100 000/µL)
- •- CRi is defined as meeting all complete remission criteria except for
- •residual absolute neutropenia < 1000/µL and/or thrombocytopenia <
- •3.Planned use of a related or unrelated donor or with no more than 1
- •antigen mismatch or planned use of a haploidentical donor
- •4.Life expectancy = 6 months at screening.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •6.Male or female, age = 18 years and = 75 years.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •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
- •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.
研究者
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