2024-512752-38-00暂停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 in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT)
Priothera S.A.S.43 个研究点 分布在 6 个国家目标入组 104 人开始时间: 2024年8月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 104
- 试验地点
- 43
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
- To demonstrate the superior efficacy of mocravimod 3 mg to that of placebo in the TAC GvHD prophylaxis stratum
- To demonstrate the superior efficacy of mocravimod 1 mg to that of placebo in the TAC GvHD prophylaxis stratum
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
- •Subjects with European LeukemiaNet (ELN) high risk or intermediate risk or AML in CR1, or AML of any risk in CR
- •(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 <100 000/μL
- •Planned use of a related or unrelated donor or with no more than 1 antigen mismatch or planned use of a haploidentical donor
- •Life expectancy ≥ 6 months at screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Male or female, age ≥ 18 years and ≤ 75 years.
排除标准
- •Planned use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis.
- •Subjects having received prior allogeneic HCT or recipients of a solid organ transplant.
- •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.
- •Require treatments for cardiac dysfunction
- •Subjects with acute promyelocytic leukemia.
- •Blast crisis of chronic myeloid leukemia
- •Cardiac dysfunction
- •Pulmonary dysfunction.
- •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
- •Renal dysfunction with creatinine clearance < 45 mL/min by the Cockcroft-Gault formula.
- •History of stroke or intracranial hemorrhage within 1 year prior to screening.
- •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.
- •Planned use of serotherapy during conditioning, including ATG and alemtuzumab.
- •Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection.
结局指标
主要结局
Relapse-free survival (RFS)
Relapse-free survival (RFS)
次要结局
- Overall Survival (OS) - mocravimod's effect on OS to that to placebo
- RFS at EOS (End-of-study) - to assess the sustained efficacy of moc in comparison to placebo
- Survival free from Grade III/IV aGvHD at 12 mo & time to acute GvHD
- Survival free from moderate /severe cGvHD at EOS & time to cGvHD
- GRFS (GvHD-free, Relapse-free survival at 12 mo and at EOS)
研究者
Stephan Oehen
Scientific
Priothera S.A.S.
研究点 (43)
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