A Phase ll, Multi-center, Single-arm Clinical Study of Low-dose Chidamide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Relapse-free survival(RFS)
研究概览
简要总结
Clinical Study on the Safety and Effectiveness of low-dose chidamide maintenance therapy after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or T-cell lymphomas.
详细描述
This is a phase ll, multi-center, single-arm clinical study.This study is indicated for high-risk of T-cell acute lymphoblastic leukemia or T-cell lymphomas patients. It aims to evaluate the safety and effectiveness of low-dose chidamide maintenance therapy after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or T-cell lymphomas to prevent relapse. 44 patients will be enrolled. The clinical end points include relapse-free survival, acute or chronic GVHD, non-relapse mortality, and overall survival, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T-cell acute lymphoblastic leukemia or T-cell lymphomas (mainly including peripheral T-cell lymphoma, NK/T-cell lymphoma, T-lymphoblastic lymphoma, etc.) must be diagnosed before enrollment. The diagnostic criteria refer to the 2016 WHO classification. Patients is in high-risk group or standard-risk group with MRD-positive patients after transplantation.
- •Stable hematopoietic reconstitution after receiving allogeneic hematopoietic stem cell transplantation, no aGVHD or stable aGVHD control and stable primary disease;
- •Complete donor chimerism after transplantation;
- •During the screening period after transplantation (within 4 weeks before Chidanilide administration), the primary disease is remission and MRD is negative.
- •Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-2 points;
- •Creatinine clearance ≥ 60 mL/min (according to the Cockcroft-Gault formula);
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal range (ULN), total bilirubin ≤ 2 × ULN;
- •Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%
- •Life expectancy >8 weeks;
- •Voluntarily sign the informed consent form, understand and comply with the requirements of the research.
排除标准
- •Bone marrow recurrence or extramedullary recurrence after transplantation;
- •Hemocytopenia after transplantation: white blood cells <2000/ul, platelets <25000/ul;
- •Active grade 3-4 acute GVHD, or active moderate-to-severe chronic GVHD that cannot be controlled by drugs;
- •Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.;
- •Currently suffering from clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, prolonged QTc interval of electrocardiogram, uncontrolled uncontrolled hypertension, congestive heart failure, any New York Heart Association (NYHA) functional class 3 or 4 cardiac disease, or a history of myocardial infarction within 6 months before screening;
- •Other serious diseases that may limit patients to participate in this trial (such as advanced infection, uncontrolled diabetes, renal failure);
- •Known human immunodeficiency virus (HIV) infection, or hepatitis B virus that cannot be controlled by drugs (HBV-DNA positive, and HBV DNA test value above the upper limit of normal value) or hepatitis C virus (anti-HCV positive, and HCV viral titer detection value above the upper limit of normal value) Chronic Infect;
- •Pregnant or lactating women;
- •Those who cannot understand and follow the research protocol or cannot sign the informed consent form;
研究组 & 干预措施
low-dose chidamide maintenance therapy after allo-HSCT
干预措施: Chidamide (Drug)
结局指标
主要结局
Relapse-free survival(RFS)
时间窗: At Year 2
The time from the date of treatment to the occurrence of any of the following: 1. Death from any cause 2. Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
次要结局
- Changes in t lymphocyte subsets(At Year 2)
- Adverse effects(At Year 2)
- GVHD-free-relapse-free survival(GRFS)(At Year 2)
- Graft-versus-host disease (GVHD)(At Year 2)
- Non-relapse mortality (NRM)(At Year 2)
- Measurable residual disease(MRD) status(At Year 2)
- Overall survival (OS)(At Year 2)
研究者
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University