NCT06286228尚未招募不适用
Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 43
- 主要终点
- register hematologic patients with haploidentical hematopoietic stem cell transplantation
研究概览
简要总结
The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:
- 1-year progression free survival rate
- 1-year overall survival rate
- Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
- Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
- Rate of Neutrophil and platelet engraftment
- Efficacy of donor specific antibody desensitization
- Relapsed rate
- Primary and late graft failure
- Safety and complication of haploHSCT
- Complication of viral, bacterial, and fungal infection
- Viral reactivation
- Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
- Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including
- •Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)
- •Lymphoid disease (acute lymphoblastic leukemia, lymphoma)
- •severe aplastic anemia
- •Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •normal AST and ALT, creatinine <2g/dL, and left ventricular ejection fraction ≥50%
- •age >18 years
- •Capable of informed consent and provision of written informed consent before any study procedures
- •Capable of attending all study visits according to the study schedule
- •Female subjects who is childbearing potential must have a negative result for pregnancy test
排除标准
- •HIV infection, active hepatitis B, active hepatitis C
- •active infection
- •history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ
- •A pregnant woman and/or refusal of contraception
结局指标
主要结局
register hematologic patients with haploidentical hematopoietic stem cell transplantation
时间窗: 5 years
次要结局
- Viral reactivation(during admission)
- overall survival rate(1 year)
- Relapsed rate(5 years)
- progression free survival rate(1 year)
- Chronic Graft-versus-host free relapsed free survival(at 180-day and 1-year)
- Rate of Neutrophil and platelet engraftment(during admission)
- cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT(5 years)
- Primary and late graft failure(5 years)
- Efficacy of donor specific antibody desensitization(during admission)
- Complication of viral, bacterial, and fungal infection(during admission)
- outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT(5 years)
- Safety and complication of haploHSCT(5 years)
研究者
Chutima Kunacheewa
lecturer
Siriraj Hospital
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