An Open Label, Non-randomized, Clinical Study of Chinese Medicine, Sheng-Yu-Tang, for Immune Reconstitution Following Peripheral Blood Stem Cell Transplantation in >CR1 (Complete Remission) and Refractory Acute Leukemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Peripheral blood Immune reconstitution
研究概览
简要总结
The treatment options for high-risk acute leukemia patients are limited and these patients are often opt for hematopoietic stem cell transplant (HSCT). However studies show that prognosis following this last-resort therapy is bleak. At times, less than 70% of post-HSCT relapsed AML and ALL patients even achieve complete remission; median overall survival of these cohorts might not reach one year; and 3-year post-HSCT survival rates might be less than 20%.
The investigators plan to recruit acute leukemia patients from CMUH which are planned to receive HSCT, and follow the rate and quality of their immune reconstitution. As intervention, part of the patients will receive a Chinese medicine herbal formula, which they will take for 6 months.Differences between the 1-year post-HSCT condition of patients will be examined.
详细描述
We hope to enroll 50 high-risk acute leukemia patients after receiving HSCT at China Medical University Hospital. Thereupon, patients will be consecutively recruited to treatment group (25 patients) where they will be prescribed Sheng Yu Tang (聖愈湯, SYT) 2 months following HSCT, for a period of 6 months, in conjunction with the standard-care treatment. We predict that not all patients will be interested in taking SYT, patients which are not interested in entering treatment group will be offered to join a control group (25 patients) which will receive standard-care treatment.
Since HSCT patients go through routine blood examinations, this study will request to extract a further 20ml of peripheral blood once a month and an additional 20ml of bone marrow at beginning of HSCT and the following routine aspirations (est.:0, +3, +6, +9, +12 month). Both treatment and control group will be required to contribute peripheral blood and bone marrow sample.Blood samples will be collected until patients reach 1-year post-HSCT, and flow cytometry will be used to examine the difference in immune reconstitution rate between the two groups. As secondary outcome measurements, this study will make use of the minimal residual disease (MRD) measured, frequency of opportunistic infections, hospitalizations and results of other routine check-up which recorded in patient history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Discharged from hospital.
- •Diagnosed with ALL, AML or MDS-AML.
- •Received allogeneic or haploidentical peripheral blood HSCT.
- •Willing to supply blood samples for analysis.
- •Willing to comply with all study interventions and follow-ups.
排除标准
- •unable, due to known allergy or any other reason, to orally take Chinese Herbal Medicine.
研究组 & 干预措施
Sheng-Yu-Tang
Treatment group will receive standard of care, as well as:
2-3 months post-HSCT, patients will be administered the herbal formula Sheng-Yu-Tang (聖愈湯), which they will receive for 6 months. The herbal formula will be provided from a GMP herbal company and will be given in granulated form.
干预措施: Sheng-Yu-Tang (Dietary Supplement)
Control
Control group will receive standard of care
结局指标
主要结局
Peripheral blood Immune reconstitution
时间窗: 1 year
次要结局
- Minimal residual disease (MRD)(1 year)
- Bone marrow Immune reconstitution(1 year)
- complete blood count(1 year)
- opportunistic infection(1 year)
- GvHD(1 year)
- frequency of hospitalizations(1 year)
- Quality of Life(1 year)
研究者
Hung-Rong Yen
Dr. Hung-Rong Yen, MD, PhD
China Medical University Hospital