Combined Haploidentical-Cord Blood Transplantation for Adults and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Neutrophil Engraftment
研究概览
简要总结
The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation.
- •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(PFT's)
- •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
High Risk Patients eligible for radiation
干预措施: Stem Cells Collections (Procedure)
Good Risks patients
For patients transplanted in remission.
干预措施: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG) (Drug)
Good Risks patients
For patients transplanted in remission.
干预措施: Stem Cell Transplant (Procedure)
Good Risks patients
For patients transplanted in remission.
干预措施: Stem Cells Collections (Procedure)
High Risk Patients eligible for radiation
干预措施: Stem Cell Transplant (Procedure)
High Risk Patients eligible for radiation
干预措施: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI) (Drug)
High Risk Patients not eligible for radiation
干预措施: Stem Cell Transplant (Procedure)
High Risk Patients not eligible for radiation
干预措施: Stem Cells Collections (Procedure)
High Risk Patients not eligible for radiation
干预措施: Fludarabine, Busulfan, and ATG (Drug)
结局指标
主要结局
Percentage of Participants With Neutrophil Engraftment
时间窗: Transplant (Day 0) through Day +28
Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC \<500/mm3 and platelet count \< 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity \< 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to \< 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.
次要结局
- Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)(Up to 2 years)
- Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years(up to 5 years)