NCT00112567已完成1 期
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.
PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD34-positive-selected haploidentical allogeneic peripheral blood stem cell transplantation in young patients with life-threatening hematologic malignancies.
Secondary
- Determine the risk for severe graft-vs-host disease in patients treated with this regimen.
- Determine the kinetics of immune reconstitution in patients treated with this regimen.
- Determine the risk for life-threatening infections in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of a life-threatening hematologic malignancy, including any of the following:
- •Acute leukemia advanced beyond first remission
- •Acute leukemia in first remission* with very high-risk prognostic features, including any of the following:
- •Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)
- •ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality
- •Hypodiploid ALL
- •Failed to achieve first remission within 1 month after induction therapy
- •Secondary AML
- •Myelodysplastic syndromes with International Prognostic Index score > 1
- •Chronic myelogenous leukemia in accelerated or blast phase NOTE: *Must be approved by PCC
- •Haploidentical family donor available
- •No suitable HLA-matched related or unrelated donor available
- •No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Not specified
- •SGPT and SGOT < 2 times upper limit of normal (ULN)*
- •Bilirubin < 2 times ULN* NOTE: *Unless due to malignancy
- •Not specified
- •Cardiovascular
- •Ejection fraction ≥ 45%
- •DLCO ≥ 60% of predicted
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No second bone marrow transplantation, after a first regimen containing total body irradiation
- •No concurrent growth factors until day 21 post-transplantation
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Biologic therapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Safety
次要结局
- Risk of severe graft-versus-host disease
- Kinetics of immune reconstitution
- Risk of life-threatening infections
研究者
研究点 (2)
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