NCT00010400已完成不适用
Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
研究概览
简要总结
OBJECTIVES:
I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide.
II. Determine the toxicity of this drug in these patients.
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, and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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--
- •Diagnosis of life-threatening systemic lupus erythematosus (SLE); must show at least 4 American College of Rheumatology criteria for SLE; must have severe organ damage in 1 or more organs; must have 1 or more of the following indications of ongoing disease activity: disease activity score (SLEDAI) at least 4, hospitalization for disease activity within 12 months, life-threatening disease not captured on SLEDAI
- •Diagnosis of antiphospholipid antibody syndrome by the Hughes criteria; must show severity by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy
- •-Patient Characteristics--
- •Hepatic: Bilirubin no greater than 2.0 mg/dL; transaminases no greater than 2.0 times normal
- •Renal: Creatinine no greater than 3.0 mg/dL
- •Cardiovascular: Ejection fraction at least 45%
- •Pulmonary: FVC, FEV1, or DLCO at least 50% predicted
- •Other: Not preterminal or moribund; not pregnant or nursing; 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: filgrastim (Drug)
未命名试验
干预措施: Cyclophosphamide (Drug)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Cyclophosphamide Therapy for Refractory Antibody-Mediated Rejection (AMR) in Kidney TransplantsAntibody Mediated RejectionNCT01630538University of Manitoba4
已完成
2 期
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic DiseaseFelty SyndromeAnemia, Hemolytic, AutoimmunePurpura, ThrombocytopenicAutoimmune DiseasesNCT00010387Johns Hopkins University32
已完成
1 期
Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple SclerosisMultiple SclerosisNCT00017628Northwestern Memorial Hospital20
已完成
2 期
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory PemphigusPemphigusNCT00010413Johns Hopkins University35
已完成
2 期
Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaParoxysmal Hemoglobinuria, NocturnalAplastic AnemiaNCT00004464Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins69