NCT01015742Unknown2 期
Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hematologically & Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission
- •Aged 1 year to 50 years
- •Absence of HLA compatible related or other related donor.
- •Availability of suitable UCB units.
- •karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) : 80- 100
- •Adequate renal function defined as:Serum creatinine <1.5 x normal,
- •Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal
- •Adequate cardiac function defined as: Ejection fraction >50% by echocardiogram.
- •Adequate pulmonary function defined as:Uncorrected DLCO 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air
排除标准
- •Age: < 1year or > 50 year
- •Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor
- •karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) < 80
- •HIV positive patients.
- •Female patients who are pregnant or breast feeding
- •Life expectancy severely limited by diseases of vital organs other than the disease indication for transplant
- •Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
- •Serious psychiatric/ psychological disorders
- •Absence of /inability to provide informed consent
- •Clinical or Paraclinical evidence of CNS or PNS involvement
研究组 & 干预措施
Experimental
Experimental
Stem cell Transplant using two unrelated umbilical cord blood units.
干预措施: Stem cell Transplantation (Drug)
结局指标
主要结局
To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
时间窗: Until end of study
次要结局
- Neutrophil and platelet engraftment(1 year)
- Severity of acute graft-vs-host disease(GvHD(1 year)
- Early transplant related mortality(100 days)
- Overall and disease free survival at one years(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Double Cord Blood Transplant for Patients With Malignant and Non-malignant DisordersImmunodeficienciesLymphomaLeukemiaAnemiaNeuroblastomaNCT00801931Columbia University1
已完成
不适用
Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric CancersAdvanced Gastric CarcinomaNCT05545293West China Hospital100
Unknown
1 期
Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke PaientsUmbilical Cord BloodErythropoietinSafetyTreatment OutcomeStrokeNCT04013646Bundang CHA Hospital24
已完成
不适用
A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian SkinMelasmaLentiginesNCT02385994Cutera Inc.80
已完成
不适用
Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological SuppressionHIV InfectionNCT02491242Asociacion para el Estudio de las Enfermedades Infecciosas155