NCT00317785已完成2 期
A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Non-relapse mortality (NRM) at 200 days
研究概览
简要总结
RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.
详细描述
OBJECTIVES:
Primary
- Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation, in terms of day 200 nonrelapse mortality, in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the rate of relapse in patients treated with this regimen.
- Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen.
- Determine the occurrence of acute renal failure in these patients.
- Determine the occurrence of respiratory failure in these patients.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following:
- •Chronic myelogenous leukemia
- •Acute myeloid leukemia
- •Acute lymphocytic leukemia
- •Myelodysplastic syndromes
- •Patients who have bulky tumor mass must not require additional involved-field irradiation
- •Planning to undergo conditioning for transplantation at the Seattle Cancer Care Alliance and University of Washington Medical Center
- •Must have an HLA-matched donor available
- •No donors who are mismatched for > 1 HLA class I antigen or allele
- •Negative anti-donor lymphocytotoxic crossmatch
- •PATIENT CHARACTERISTICS:
- •Life expectancy must not be severely limited by diseases other than malignancy
- •No moribund patients
- •Creatinine ≤ 1.2 mg/dL
- •Oxygen saturation on room air ≥ 93%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No HIV positivity
- •No cirrhosis
- •No hepatic fibrosis with bridging
- •No fulminant hepatic failure
- •No acute liver injury
- •No persistent cholestasis
- •No infection requiring systemic antibiotic or antifungal therapy
- •No coronary artery disease
- •No congestive heart failure requiring therapy
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior hematopoietic stem cell transplantation
- •No prior radiation therapy to the liver or adjacent organs
- •More than 30 days since prior cytoreductive chemotherapy for patients with a large body burden of tumor cells
- •No concurrent enrollment in a phase I study
排除标准
- 未提供
结局指标
主要结局
Non-relapse mortality (NRM) at 200 days
次要结局
- Overall survival
- Relapse rate
- Sinusoidal obstruction syndrome (SOS)
- Acute renal failure
- Respiratory failure
- Cause of death
研究者
研究点 (2)
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