Chidamide Plus PTCy/Cyclosporine to Prevent GVHD After Myeloablative Conditioning, Matched PBSCT
Chidamide Plus Post-transplantation Cyclophosphamide and Cyclosporine to Prevent Graft-versus-host Disease After Myeloablative Conditioning, Matched Peripheral-blood Stem-cell Transplantation
研究概览
详细说明
Eligible patients were aged 16 to 65 years, diagnosed with hematologic malignancy, and had a Karnofsky performance score of ≥70% and were candidates for myeloablative HCT. A 8/8 HLA allelic match between the donor and the recipient at HLA-A, HLA-B, HLA-C, and HLA-DRB1 by high-resolution typing was required. The graft source was PBSC.
Patients received a myeloablative conditioning regimen consisting of oral chidamide given twice weekly at a dose of 20 mg from day -7 to 2 weeks post transplantation, intravenous busulfan 3.2 mg/kg from day -6 to -3, intravenous fludarabine 30 mg/m2 and cytarabine 1g/m2 respectively from day -6 to -2. PBSCs were infused on day 0. GVHD prophylaxis was post-transplantation cyclophosphamide (50 mg/kg on day +3, +4) and cyclosporine (started from day +5). In the absence of GVHD, cyclosporine tapering started on day +100 and discontinued on day +180. Minimal residual disease (MRD) was determined by multi-parameter flow cytometry.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Sichuan
-
Chengdu、Sichuan、中国、610044
- West China Hospital of Sichuan University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 16 years or older, and ≤ 65 years at time of enrollment
- Signed informed consent
- Hematologic disorder requiring allogeneic hematopoietic cell transplantation
- Left ventricular ejection fraction (LVEF) ≥ 45% by multiple uptake gated acquisition (MUGA) scan or echocardiogram
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing lung capacity oxygenation (DLCO) adjusted ≥ 50% of predicted values on pulmonary function tests
- Transaminases (AST, ALT) < 3 times upper limit of normal (ULN) values
- Creatinine clearance calculated ≥ 50 mL/min
- Karnofsky Performance Status Score ≥ 60%.
- Human leukocyte antigen (HLA) matched 8/ (A, B, C, DRB1) related or unrelated donor
Exclusion Criteria:
- Active infection not controlled with appropriate antimicrobial therapy HIV, hepatitis B (HBcAb positive but HBsAg negative with undetectable viral load are eligible), or hepatitis C infection
- Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) ≥4
- Anti-thymocyte globulin (ATG) as part of the conditioning regimen
- Pregnancy
- Histone deacetylase (HDAC), DAC, HSP90 inhibitors or valproic acid for the treatment of cancer within 30 days
- Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first chidamide treatment
- Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: Any history of ventricular fibrillation or torsade de pointes; Bradycardia defined as heart rate (HR)< 45 bpm (Patients with pacemakers are eligible if HR ≥ 45 bpm); Screening electrocardiogram (ECG) with a QTcF > 480 msec; Right bundle branch block + left anterior hemiblock (bifascicular block); Patients with myocardial infarction or unstable angina ≤ 12 months prior to starting study drug; Other clinically significant heart disease (e.g., New York Heart Association (NYHA) class III or IV , uncontrolled hypertension) as per discretion of principal investigator and/or treating physician; Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug with the exception of drugs listed on Appendix B of study documents that are required for hematopoietic cell transplantation (HCT) patients.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Chidamide
Chidamide, tablets, 5 mg/tablet, 20 mg orally twice weekly from D-7~+14 Cyclophosphamide: 50 mg/Kg intravenously D+3, +4 Cyclosporine A: intravenously then orally 3 mg/Kg D+5~D+100
|
20 mg orally, twice weekly from D-7 to D+14
其他名称:
50 mg/Kg intravenously D+3, +4
3 mg/Kg intravenously then orally from D+5 to D+100 if no acute graft-versus-host disease
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
aGVHD
大体时间:100 day after infusion of PBSCs
|
accumulated incidence of aGVHD
|
100 day after infusion of PBSCs
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
GRFS
大体时间:3 years after recruitment
|
GVHD free, relapse free survival
|
3 years after recruitment
|
|
DFS
大体时间:3 years after recruitment
|
Disease free survival
|
3 years after recruitment
|
|
OS
大体时间:3 years after recruitment
|
Overall survival
|
3 years after recruitment
|
|
cGVHD
大体时间:2 yeas after infusion of PBSCs
|
accumulated incidence of cGVHD
|
2 yeas after infusion of PBSCs
|
合作者和调查者
调查人员
- 学习椅:Ting Liu, MD、West China Hospital
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
材料数据表的临床试验
-
Array BioPharma完全的反洗钱 | 晚期和选定的实体瘤 | 高风险和极高风险 MDS美国, 澳大利亚, 意大利, 西班牙, 法国, 瑞士, 英国
-
Singapore Eye Research Institute未知
-
Gruppo Italiano Malattie EMatologiche dell'Adulto招聘中
-
Technische Universität Dresden尚未招聘MDS(骨髓增生异常综合征) | 意义未明的 CCUS 克隆性血细胞减少症 | MDS/骨髓增生性肿瘤 (MPN) 重叠综合征 | CHIP德国
Chidamide的临床试验
-
Shanghai Changzheng Hospital招聘中三线治疗中的晚期结直肠癌 | PMMR/MSS晚期结直肠癌中国
-
The First Hospital of Jilin University招聘中
-
The First Affiliated Hospital with Nanjing Medical...招聘中
-
The First Affiliated Hospital of Soochow University招聘中
-
The Affiliated Hospital of Xuzhou Medical University尚未招聘PD-1抑制剂 | 替诺福韦 | 西达本胺 | 来那度胺 | 与EBV相关的淋巴增生性疾病
-
Chinese PLA General HospitalThe General Hospital of Western Theater Command; First Affiliated Hospital of Harbin Medical... 和其他合作者招聘中
-
The Affiliated Hospital of Xuzhou Medical University尚未招聘PD-1抑制剂 | 替诺福韦 | 西达本胺 | EB 病毒 (EBV) 感染 | 来那度胺