NCT00251277撤回1 期
Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Failure to maintain the complete response until day 120; Non-protocol treatment for TTP, such as other immunosuppressive agents or splenectomy, reinstitution of plasma exchange within the first 90 days
研究概览
简要总结
The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP). This includes evaluating the rate and type of treatment failure.
详细描述
With this study we hope to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP). This includes evaluating the rate and type of treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the trial based on the following criteria:
- •Patients must have TTP with platelet count < 100,000/mL and microangiopathic hemolytic anemia which is defined as presence of at 3-10 fragmented red blood cells (schistocytes) per high power filed on the peripheral blood smear.
- •Either gender, age 17 or older
- •Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- •TTP not related to underlying cancer, treatment of cancer or transplantation
- •New onset TTP, or previously diagnosed TTP with an unmaintained remission for >12 months.
- •LDH >2X upper limit of normal
- •Prothrombin time (PT), partial thromboplastin time (PTT) normal
- •Direct antiglobulin test (DAT) negative
- •Subject has provided written informed consent
- •Patients who have received up to 3 plasmapheresis.
排除标准
- •Patients will be excluded from the trial based on the following criteria:
- •A diagnosis of AIDS. Patients with HIV infection with absolute CD4 counts >200/ul and no active, significant opportunistic infection are eligible
- •Patients with a known hepatitis C infection (HCV) and/or with hepatitis B
- •Patients receiving pheresis more than once a day
- •Recent (within 1 year) bone marrow or hematopoietic stem cell transplant
- •Patient is on calcineurin inhibitors, or is unable to come off them
- •Acute or chronic disseminated intravascular coagulation (DIC), defined by D-dimers >8mg/ml and fibrinogen < 100 mg (0.1g)/dl
- •A diagnosis of metastatic or non-metastatic malignancy other than basal cell carcinoma.
- •Malignant hypertension (systolic blood pressure [BP] > 200 mm Hg or a diastolic BP > 130 mm Hg)
- •Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment). Eligibility resumes 3 days after delivery
- •Patients with family history of or a previous diagnosis of congenital TTP
- •Patients with hemolytic uremic syndrome (HUS)
- •Patients with sepsis
结局指标
主要结局
Failure to maintain the complete response until day 120; Non-protocol treatment for TTP, such as other immunosuppressive agents or splenectomy, reinstitution of plasma exchange within the first 90 days
时间窗: Four months
次要结局
未报告次要终点
研究者
James B. Bussel
Professor of pediatrics
Weill Medical College of Cornell University
研究点 (1)
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