NCT00010413已完成2 期
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES:
I. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.
详细描述
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Definitive diagnosis of pemphigus, including all of the following: Typical clinical lesions Histologically proven by skin or mucous membrane biopsy Pemphigus IgG autoantibodies in skin or mucous membrane by direct immunofluorescence (IF) Circulating pemphigus IgG autoantibodies in serum by indirect IF
- •Dependence on high-dose corticosteroids
- •Persistent disease activity despite treatment with mycophenolate mofetil or azathioprine, or inability to tolerate these drugs (for paraneoplastic pemphigus, persistent disease activity despite treatment with cyclosporine)
- •-Prior/Concurrent Therapy--
- •No concurrent cytotoxic therapy
- •-Patient Characteristics--
- •Performance status: Karnofsky 20-100%
- •Renal: Creatinine no greater than 2.5 mg/dL
- •Cardiovascular: LVEF at least 40%
- •Pulmonary: FVC, FEV1, or DLCO at least 50% predicted
- •Other: Not pregnant Fertile patients must use effective contraception during and for 9 months after study Not preterminal or moribund
排除标准
- 未提供
研究者
研究点 (1)
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