Combined Haploidentical-Cord Blood Transplantation for Adults and Children
2021年1月8日 更新者：University of Chicago
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).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
87
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Illinois
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Chicago、Illinois、美国、60637
- The University of Chicago
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Good Risks patients
For patients transplanted in remission.
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Fludarabine is given through the vein daily for 5 days.
Melphalan is given through the vein daily for 2 days.
ATG is given every day in the vein for four days.
Infusion of haploidentical donor, umbilical cord blood
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
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实验性的：High Risk Patients eligible for radiation
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Infusion of haploidentical donor, umbilical cord blood
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Fludarabine is given through the vein daily for 5 days.
Thiotepa is given through the vein daily for 2 days.
ATG is given through the vein every other day for 4 days.
TBI is given twice a day for 3 days.
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实验性的：High Risk Patients not eligible for radiation
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Infusion of haploidentical donor, umbilical cord blood
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Fludarabine is given through the vein daily for 5 days.
Busulfan is given through the vein daily for 4 days.
ATG is given through the vein every other day for 4 days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Neutrophil Engraftment
大体时间：Transplant (Day 0) through Day +28
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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.
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Transplant (Day 0) through Day +28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
大体时间：Up to 2 years
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Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al) The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported |
Up to 2 years
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Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years
大体时间：up to 5 years
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We reported overall survival at 2 years and 5 years after transplant
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up to 5 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hongtao Liu, M.D.、University of Chicago
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Liu H, Rich ES, Godley L, Odenike O, Joseph L, Marino S, Kline J, Nguyen V, Cunningham J, Larson RA, del Cerro P, Schroeder L, Pape L, Stock W, Wickrema A, Artz AS, van Besien K. Reduced-intensity conditioning with combined haploidentical and cord blood transplantation results in rapid engraftment, low GVHD, and durable remissions. Blood. 2011 Dec 8;118(24):6438-45. doi: 10.1182/blood-2011-08-372508. Epub 2011 Oct 5.
- van Besien K, Hari P, Zhang MJ, Liu HT, Stock W, Godley L, Odenike O, Larson R, Bishop M, Wickrema A, Gergis U, Mayer S, Shore T, Tsai S, Rhodes J, Cushing MM, Korman S, Artz A. Reduced intensity haplo plus single cord transplant compared to double cord transplant: improved engraftment and graft-versus-host disease-free, relapse-free survival. Haematologica. 2016 May;101(5):634-43. doi: 10.3324/haematol.2015.138594. Epub 2016 Feb 11.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2006年10月9日
初级完成 (实际的)
2018年9月1日
研究完成 (实际的)
2018年9月1日
研究注册日期
首次提交
2009年7月20日
首先提交符合 QC 标准的
2009年7月21日
首次发布 (估计)
2009年7月22日
研究记录更新
最后更新发布 (实际的)
2021年1月27日
上次提交的符合 QC 标准的更新
2021年1月8日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 14736B
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