NCT00161564撤回2 期
A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard doses of rituximab.
详细描述
Primary Objectives
- Efficacy: The primary objective (primary endpoint) is to determine the rate of response (partial or complete response) at week 16 (± 2) post-treatment in both pilot arms: the high dose Rituximab (or HDR) group (750 mg/m2 x 4) and the group treated with a regimen combining standard doses of Rituximab with CVP (R-CVP.) A complete response (CR) will be a platelet count increase ³ 150,000/mL on two consecutive occasions one week apart, without any other therapy. A partial response will be considered if the platelet count increases between 50 and 150,000/mL.
- Safety: To assess and compare the incidence of moderate and severe adverse-events including the number and type of infections in both arms of the study using Genentech standard safety monitoring and serious adverse event (SAE) reporting.
Secondary Objectives
- To compare the response rate in the 2 treatment arms in the "Rituximab non-responders" sub group (see 4.1 for definition)
- To compare the response rate in the 2 treatment arms in the " Rituximab relapsers" subgroup
- To assess the mean duration of response (PR or CR) in the 2 treatment arms.
- To evaluate the duration of very low to absent peripheral blood B cells in the two treatment arms.
- To assess the incidence of hypogammaglobulinemia (IgG and/or IgM level < ½ of lower limit of normal for age) and white blood counts in the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible to participate in the study if they:
- •Have chronic ITP19 (> 6 months duration).
- •Have received Rituximab a minimum of 3 months prior to entry.
- •Have received no more than 2 courses of Rituximab at standard dose separated by a minimum of 12 weeks.
- •Have not achieved a durable response to Rituximab, with platelet counts < 30,000/ml when not supported by other treatment.
- •Have a platelet count of < 30,000/ul on two separate occasions 1-2 weeks apart within the past month prior to the inclusion.
- •Are age ≥ 12 years old.
- •Had a splenectomy at least 60 days prior to study entry, or a contraindication to splenectomy.
- •Give written informed consent.
- •Use an effective means of contraception during treatment and for six months after completion of treatment.
- •Have negative serum pregnancy test, for all women who are able to have children, within 14 days prior to study entry.
排除标准
- •Male and female subjects will be ineligible to participate if they:
- •Received prior treatment with cyclophosphamide within the last 3 months.
- •Received prior treatment with > 4 infusions of vinca alkaloids within the 6 months.
- •Had previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.
- •Have an HIV infection.
- •Have hepatitis Bs antigen positivity or active hepatitis C infection
- •Have an absolute neutrophil count < 1.000/mm3 at study entry (unless related to autoimmune neutropenia).
- •Have a Hemoglobin level < 10 g/dl other than caused by thalassemia trait, iron deficiency or autoimmune hemolytic anemia (patients with Evan's syndrome will not be excluded).
- •Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL.
- •Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an AST or ALT level > 3x upper limit of normal.
- •Have active infection requiring antibiotic therapy within 7 days prior to study entry.
- •Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug.
- •Have had a prior severe reaction to Rituximab, leading to discontinuation of treatment.
- •Have a New York Heart Classification III or IV heart disease.
- •Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures.
研究者
研究点 (1)
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