Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma
Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin's Lymphoma
研究概览
详细说明
Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkin's lymphoma (NHL). Standard chemotherapy cures less than 40% of patients. When patients relapse, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Multiple studies have shown the value of high-dose chemotherapy, with increased disease-free survival and overall survival, when compared with second-line conventional chemotherapy. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it, and other treatment strategies are needed to improve the cure rate.
Another treatment option called immunotherapy is being tested in lymphoma patients. Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma. For example, NHL cells have a protein called CD20 on their surface. Rituximab is an antibody directed against the CD20 protein, which may result in the death of the lymphoma cell. Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients.
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- The University of Michigan
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically documented, aggressive and/ or intermediate grade and high-grade B cell NHL, CD20 positive.
- In relapse after primary conventional chemotherapy
- Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse
- Treatment of CNS or meningeal disease (cytology-negative CSF) if present
- Treatment of CNS or meningeal disease (cytology-negative CSF) if present.
- Cumulative total doxorubicin dosage <500 mg/m2
- Performance score: 0-2
- Prior malignancies eligible if treated for cure and without active disease
- Patients must not be pregnant or nursing.
- Prior Immunotherapy is allowed
- Signed Informed Consent
- Absolute neutrophil count > 1500/ µl, platelet count >100,000/ µl
- Bilirubin <1.5 x normal, SGOT <2.5 x normal
- Serum creatinine <1.5 mg/dl
- Ejection fraction > 45% or > 40% with normal wall motion
- HIV negative
- FEV1, DLCO > 50% predicted
Exclusion Criteria:
- Pregnant or nursing
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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Assess safety and toxicity after rituximab and high-dose chemotherapy
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次要结果测量
结果测量 |
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Assess CD20 depletion in leukapheresis products after rituximab and high-dose chemotherapy, and monitor CD20 recovery post-transplant
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Assess the response rate after rituximab and high-dose chemotherapy with autologous peripheral blood progenitor cell (PBPC) support, for patients with relapsed CD20+ Non-Hodgkin's lymphoma (NHL)
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Assess progression-free and overall survival after rituximab and high-dose chemotherapy with PBPC support
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合作者和调查者
调查人员
- 首席研究员：Raymond J. Hutchinson, MD、University of Michigan
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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