NCT00185523终止不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
研究概览
简要总结
The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.
详细描述
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic Phase
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Weeks 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patient age > 1 month and < 55 yo
- •Patients must have a genotypically HLA identical sibling
- •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%
- •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
排除标准
- •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
结局指标
主要结局
To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
时间窗: no known
次要结局
未报告次要终点
研究者
研究点 (1)
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