NCT05429632招募中3 期
Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 366
- 试验地点
- 170
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
This is a multi-center, randomized, double-blinded, placebo controlled trial.
详细描述
The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations
- •European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, [CRi] is also allowable
- •Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft
- •Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
- •Planned use of TAC-based GvHD prophylaxis
- •age ≥ 18 years and ≤ 75 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
- •Diagnosis of macular edema during screening
- •Cardiac/pulmonary/hepatic/renal dysfunction
- •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 mg/dL
- •Renal dysfunction with estimated creatinine clearance < 45 mL/min by the Cockcroft-Gault formula
- •Diabetes mellitus
- •History or presence of uveitis at screening
- •History or diagnosis of macular edema
研究组 & 干预措施
3mg mocravimod arm
Experimental
3 mg of mocravimod orally once per day for 12 months
干预措施: mocravimod (Drug)
1mg mocravimod arm
Experimental
1 mg of mocravimod orally once per day for 12 months
干预措施: mocravimod (Drug)
Placebo arm
Placebo Comparator
placebo orally once per day for 12 months
干预措施: mocravimod (Drug)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: 12 months
To compare the efficacy of mocravimod to that of placebo
次要结局
- Overall survival (OS)(24 months)
研究者
研究点 (170)
Loading locations...
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