Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:
- acute myelogenous leukemia, 1st or 2nd remission
- acute lymphoblastic leukemia, 1st or 2nd remission
- chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age > 1 month and < 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows:
a. total bilirubin <2.5 and SGOT/SGPT <2x normal b. adequate renal function as defined by creatinine < 1.5 or a 24 hr creatinine clearance >50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine > 1.5) c. DLCO > 60% predicted d. radionuclide cardiac scan with ejection fraction >45% 5. Patient must be competent to give consent.
Inclusion criteria (Donor):
- HLA identical family member
- Donor or guardian must be competent to give consent
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
Exclusion Criteria:3.2 Exclusion Criteria (Patient):
- Evidence of active infection or active hepatitis
- Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
- Previous allogeneic stem cell/bone marrow transplant
- Pregnant or lactating patients
4 Exclusion criteria (Donor):
- Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
- Donors who are HIV+ or hepatitis B antigen +
- History of allergic reaction to G-CSF
- Female donors must be post-menopausal or have a negative pregnancy test
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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CML in first Chronic Phase or Accelerated Phase
Busulfan/cyclophosphamide Day -7: Busulfan 1.0 mg/kg IV q6 hrs** Day -6: Busulfan 1.0 mg/kg IV q6 hrs Day -5: Busulfan 1.0 mg/kg IV q6 hrs Day -4: Busulfan 1.0 mg/kg IV q6 hrs Day -3: Cyclophosphamide 60 mg/kg Day -2: Cyclophosphamide 60 mg/kg Day -1: rest Day 0: Allogeneic PBSC infusion
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AML and ALL in first or second remission
FTBI/VP-16 Day -7: FTBI 120 cGy x 3 fractions Day -6: FTBI 120 cGy x 2 fractions Day -5: FTBI 120 cGy x 3 fractions Day -4: FTBI 120 cGy x 3 fractions* Day -3: VP-16 at 60 mg/kg Day -2: rest Day -1: rest Day 0: Allogeneic PBSC infusion
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
大体时间:no known
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no known
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合作者和调查者
调查人员
- 首席研究员:Ginna Laport、Stanford University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
白血病的临床试验
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Shenzhen Second People's Hospital招聘中白血病 | 骨髓的 | 慢性的 | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | 积极的中国