Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

Johns Hopkins University1 个研究点分布在 1 个国家目标入组 32 人开始时间: 1999年3月1日最近更新: 2008年9月10日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Johns Hopkins University
入组人数: 32
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

OBJECTIVES:

I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

详细描述

PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment

入排标准

性别: All
接受健康志愿者: 否

入选标准

•PROTOCOL ENTRY CRITERIA:
•-Disease Characteristics--
•Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia
•Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants)
•Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3
•-Prior/Concurrent Therapy--
•See Disease Characteristics
•-Patient Characteristics--
•Age: Not specified
•Performance status: Not specified
•Hematopoietic: See Disease Characteristics
•Hepatic: Not specified
•Renal: Creatinine no greater than 2.5 mg/dL
•Cardiovascular: Ejection fraction at least 40%
•Pulmonary: FVC, FEV1, or DLCO at least 50% predicted
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective contraception
•Not preterminal or moribund

排除标准

未提供

研究者

发起方

Johns Hopkins University

申办方类型

Other

研究点 (1)

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