NCT00004643已完成2 期
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
National Center for Research Resources (NCRR)0 个研究点目标入组 10 人开始时间: 1995年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus.
II. Evaluate objective disease parameters, including serum complement levels, anti-DNA antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.
详细描述
PROTOCOL OUTLINE:
Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •Disease Characteristics
- •Clinically documented active systemic lupus erythematosus demonstrating at least 4 revised diagnostic criteria
- •Unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), topical corticosteroids, and antimalarials
- •Intolerable side effects from corticosteroids or other immunosuppressive drugs Failure on immunosuppressives not required
- •No life-threatening disease, e.g.: Lupus cerebritis Rapidly progressive glomerulonephritis
- •Prior/Concurrent Therapy
- •No concurrent other DNA synthesis inhibitors, NSAIDs, and prednisone continued on study
- •Patient Characteristics
- •Hematopoietic: WBC at least 2000; Platelets at least 100,000
- •Renal: Creatinine clearance at least 20 mL/min
- •Other: No major infection within 2 weeks prior to entry
- •Negative pregnancy test required of fertile women
- •Effective contraception required of fertile women. Advised for men during and for 75 days after therapy
排除标准
- 未提供
研究者
相似试验
进行中（未招募）
2 期
Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in ChildrenAcute Lymphoblastic LeukemiaNCT01593488National Cancer Institute, Naples31
Unknown
1 期
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)Leukemia, Myeloid, AcuteNCT02140606Jiangsu Hansoh Pharmaceutical Co., Ltd.
已完成
2 期
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDSAcute Myelogenous LeukemiaMyelodysplastic SyndromesChronic Myelogenous LeukemiaNCT00334074Baylor Research Institute30
终止
2 期
Decitabine, Cytarabine, GCSF for Refractory AML/MDSMyelodysplasiaLeukemiaNCT00740181Brown University9
已完成
2 期
A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid LeukaemiaAcute Myeloid LeukemiaNCT01035502Clavis Pharma51