NCT06712108招募中不适用
PROspective Multicenter Observational Study of Double Unit Umbilical Cord Lood Transplantation in Korean Adult Patients With Hematologic Diseases.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Overall Survival
研究概览
简要总结
The efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective observation and analysis of actual clinical data collection
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 and older
- •Patients scheduled for umbilical cord blood transplantation as a primary allogeneic hematopoietic stem cell transplantation for the treatment of the following hematologic diseases:
- •Acute leukemia (myeloid/lymphoid/mixed lineage) / Myelodysplastic syndromes / Chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms / Malignant lymphomas, multiple myeloma / Other malignant hematologic malignancies / bone marrow failure diseases, including aplastic anemia
- •- If all contents of the consent form are understood and consented to in writing.
排除标准
- •Patients with a history of allogeneic hematopoietic stem cell transplantation or those undergoing transplantation for the treatment of engraftment failure (secondary allogeneic hematopoietic stem cell transplantation is an exclusion criterion; however, patients eligible for registration include those undergoing their first allogeneic stem cell transplantation following an autologous stem cell transplantation).
- •Patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator.
- •Patients with an ECOG Performance Status (PS) greater than 3 or those receiving mechanical ventilation in the intensive care unit.
- •Patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.
研究组 & 干预措施
Adult patients with hematologic disease who will receive double unit cord blood tranplant
干预措施: tranplant (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 2 years
次要结局
- engraftment(30 days)
- GVHD(2 years)
- PFS(2 years)
- Relapse(2 years)
- TRM(3 months)
研究者
Dong-Yeop Shin
Associate Professor
Seoul National University Hospital
研究点 (6)
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