Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Cord Blood Engraftment by Day 100
研究概览
简要总结
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
详细描述
Primary Objective
- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease
Secondary Objectives
- To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
- To describe the incidence and severity of acute and chronic GVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Relapsed or refractory acute leukemia (myeloid or lymphoid)
- •Acute leukemia in first remission at high-risk for recurrence
- •Chronic myelogenous leukemia in accelerated phase or blast-crisis
- •Chronic myelogenous leukemia in chronic phase
- •Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
- •Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- •Multiple myeloma
- •Myelodysplastic syndrome
- •Chronic myeloproliferative disease
- •Hemoglobinopathies
- •Aplastic anemia
排除标准
- •Zubrod performance status > 2
- •Life expectancy is severely limited by concomitant illness
- •Patients with severely decreased LVEF or impaired pulmonary function tests
- •Estimated Creatinine Clearance <50 ml/min
- •Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
- •Evidence of chronic active hepatitis or cirrhosis
- •HIV-positive
- •Patient is pregnant
- •Patient or guardian not able to sign informed consent
研究组 & 干预措施
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
干预措施: Antithymocyte Globulin (ATG) (Drug)
Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
干预措施: Melphalan (Drug)
Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
干预措施: Fludarabine (Drug)
Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
干预措施: Antithymocyte Globulin (ATG) (Drug)
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
干预措施: Fludarabine (Drug)
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
干预措施: Busulfan (Drug)
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
干预措施: Total Body Irradiation (TBI) (Drug)
结局指标
主要结局
Cord Blood Engraftment by Day 100
时间窗: 100 days
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
次要结局
- Survival at Day 100(100 days)