A Randomized Multicenter Study Comparing Unrelated Umbilical-cord Blood Transplant Versus Human Leukocyte Antigen (HLA)-Haploidentical Related Hematopoietic Stem Cell Transplant for Adult Patients With Hematologic Malignancies

Instituto de Investigacion Sanitaria La Fe0 个研究点目标入组 206 人开始时间: 2015年3月最近更新: 2015年3月11日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 206
主要终点: Disease-Free Survival (DFS)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is an open-label, prospective, observational, multicenter, randomized study to compare the efficacy between unrelated umbilical cord blood transplantation (UCBT) and HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative conditioning for adult patients with hematologic malignancies.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age: subjects ≥ 18 and ≤ 55 years old.
•Patients without suitable matched related donor
•Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option.
•Written consent form signed.

排除标准

•Performance status: Eastern Cooperative Oncology Group(ECOG) score >2
•Prior allogenic hematopoietic stem cell transplant
•Left-ventricular ejection fraction at rest < 45%, uncontrolled arrhythmias or symptomatic heart failure.
•Diffusing capacity (DLCO) and/or forced vital capacity (FVC) < 39% of predicted values or symptomatic pulmonary disease
•Altered liver function tests (total bilirubin > 2 mg/dL and/or alanine aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis.
•Serum creatinine > 2 mg/dL or estimated creatinine clearance < 50 mL/min
•Evidence of uncontrolled bacterial, viral or fungal infection prior to the conditioning regimen
•Serious diseases that prevent patients from receiving chemotherapy treatments.
•Concomitant neoplasms.
•Pregnancy or breast-feeding.
•Any other medical, surgical or psychiatric condition that is considered by the attending and/or medical team as a contraindication for intensive treatment

结局指标

主要结局

Disease-Free Survival (DFS)

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方

Instituto de Investigacion Sanitaria La Fe

申办方类型

Other

责任方

Sponsor

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