NCT00004464已完成2 期
High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 1996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
- 入组人数
- 69
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia.
II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients.
III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.
详细描述
PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days.
Patients are followed every 3 months for at least 2 years and annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria
- •Not a candidate for allogeneic bone marrow transplantation
- •Must meet one of the following criteria:
- •Severe aplastic anemia
- •Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3
- •platelet count less than 20,000/mm3 and granulocytes less than 500/mm3)
- •Life-threatening paroxysmal nocturnal hemoglobinuria
- •Absolute neutrophil count less than 500/mm3
- •platelet transfusion dependent
- •thrombotic disease
- •No Fanconi anemia
- •No abnormal cytogenetics
- •-Patient Characteristics--
- •Renal: Creatinine no greater than 2.0 mg/dL
- •Cardiovascular: Cardiac ejection fraction at least 45%
- •Other: Not preterminal or moribund Not pregnant
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
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
撤回
2 期
High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisNCT00939549Johns Hopkins University
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
3 期
High-Dose Intravenous (IV) Cyclophosphamide Versus Monthly IV CyclophosphamideLupus Erythematosus, SystemicNCT00005778National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)100
进行中（未招募）
1 期
Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid TumorsSolid TumorsNCT02498912Memorial Sloan Kettering Cancer Center18