NCT00118326已完成1 期
Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Safety and feasibility
研究概览
简要总结
RATIONALE: A bone marrow transplant from a brother or sister may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Colony-stimulating factors, such as G-CSF, cause the body to make blood cells. Giving G-CSF to the donor may help the body make more stem cells that can be collected for bone marrow transplant and may cause fewer side effects in the patient after the transplant.
PURPOSE: This phase I/II trial is studying the side effects of donor bone marrow transplant and to see how well it works in treating young patients with cancer or a non-cancerous disease.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of filgrastim (G-CSF)-mobilized bone marrow from an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients undergoing allogeneic bone marrow transplantation for malignant or non-malignant disease.
Secondary
- Determine the time to neutrophil and platelet engraftment, number of red blood cell and platelet transfusions, number of febrile days, and number of hospitalization days in patients treated with this regimen.
- Determine the number of nucleated cells and CD34-positive cells, absolute lymphocyte count, and lymphocyte subsets (CD3/CD4/CD8) in G-CSF-mobilized bone marrow from these donors.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patients (recipients):
- •Undergoing a myeloablative or nonmyeloablative allogeneic bone marrow transplantation for 1 of the following diseases:
- •Hematologic malignancy
- •Non-hematologic malignancy
- •Non-malignant disease
- •Not undergoing T-cell depleted bone marrow transplantation
- •Healthy sibling of a patient meeting eligibility requirements for this protocol
- •HLA-identically matched with patient
- •PATIENT CHARACTERISTICS:
- •18 and under (patient and donor)
- •Performance status
- •Karnofsky 90-100% (donor) OR
- •Lansky 90-100% (donor)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No sickle cell anemia (donor)
- •Not specified
- •Not specified
- •Immunologic
- •HIV negative (patient and donor)
- •No uncontrolled bacterial, viral, fungal, or parasitic infection (donor)
- •No potentially life threatening autoimmune disease (donor)
- •Not pregnant or nursing (patient and donor)
- •Fertile patients must use effective contraception (patient)
- •No other illness that would severely limit life expectancy (patient)
- •No pre-existing medical condition that would confer a high risk for bone marrow donation (donor)
- •No medical condition or psychiatric trait that would preclude G-CSF administration or bone marrow harvesting (donor)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 years since prior allogeneic blood transfusion (donor)
- •No concurrent growth factors post-transplantation (donor)
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •Concurrent participation in another treatment clinical trial allowed provided the use of filgrastim (G-CSF)-mobilized bone marrow is not excluded (patient)
- •No other concurrent investigational agents (donor)
排除标准
- 未提供
结局指标
主要结局
Safety and feasibility
次要结局
未报告次要终点
研究者
研究点 (2)
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