Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
研究概览
简要总结
OBJECTIVES:
I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.
详细描述
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro.
Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.
Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 0 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:
- •Nephritis (WHO class III or IV)
- •Failed NIH short-course cyclophosphamide therapy
- •Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure)
- •Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following:
- •Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL
- •Platelet count less than 40,000/mm3 (without transfusions)
- •Granulocyte count less than 1,000/mm3
- •Catastrophic anti-phospholipid syndrome
- •-Patient Characteristics--
- •Cardiovascular:
- •LVEF at least 35%
- •No lupus-induced myocarditis
- •No history of unstable angina
- •FEV1/FVC at least 50% predicted
- •DLCO at least 50% predicted
- •HIV negative
- •No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer
- •No uncontrolled diabetes mellitus
- •No medical illness that would preclude study
- •No psychiatric illness or mental deficiency that would preclude study
- •No known hypersensitivity to E. coli-derived proteins
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- 未提供
研究组 & 干预措施
未命名试验
干预措施: CD34+ Peripheral Blood Stem Cell Reinfusion (Procedure)
未命名试验
干预措施: filgrastim (Drug)
未命名试验
干预措施: cyclophosphamide (Drug)
未命名试验
干预措施: anti-thymocyte globulin (Drug)