Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Intermediate Grade Non-Hodgkin's Lymphoma Following First Line CHOP
2005年6月23日 更新者:Corixa Corporation
Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP
The purpose of this study is to determine the safety and effectiveness of using Iodine-131 Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkin's lymphoma (NHL) who have achieved a response following 6-8 cycles of CHOP therapy.
研究概览
详细说明
The primary endpoint is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy.
The secondary efficacy endpoints are to determine the complete response rate, duration of response, duration of complete response, progression-free survival, and time to treatment failure.
The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose.
The secondary safety endpoints are to determine the incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time to recovery), use of supportive care, percent of patients converting to human anti-murine antibody (HAMA) positivity, and survival.
研究类型
介入性
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- Rush Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts New England Medical Center
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New York
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New York、New York、美国、10021
- Cornell Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients must have a histologically confirmed initial diagnosis of de novo diffuse large B-cell NHL according to the REAL classification. This includes the intermediate grade International Working Formulation subtypes of diffuse, mixed small cell and large cell; diffuse large cell; follicular large cell; mantle cell, and large cell immunoblastic.
- Patients must have had Ann Arbor, stage III or stage IV, or bulky Stage II disease at diagnosis.
- Patients must be less than or equal to 80 years of age with any IPI score.
- Patients must have less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with NHL is also adequate. Verification of bone marrow status must be performed at the time of response evaluation following CHOP chemotherapy and within 56 days of study enrollment.
- Patients must have been treated with 6 or more cycles of first-line CHOP chemotherapy and have achieved a PR, CRu, or CR. Patients must have available computed tomography (CT) scans of the chest, abdomen, and pelvis, and a bone marrow biopsy that were performed within 56 days prior to the start of CHOP. In addition, they must have written documentation (i.e., copies of original medical notes and radiographic reports) describing the pre-CHOP staging evaluation, the number of cycles of CHOP administered, the dose of each agent, the start and stop dates of each cycle, and the post-CHOP response evaluation. The post-CHOP response evaluation must include a CT scan of the chest, abdomen, and pelvis (gallium scan is optional). For patients who have palpable cervical lymphadenopathy, a CT scan of the neck must be performed following CHOP chemotherapy. The CHOP chemotherapy should consist of standard doses of each agent, although dose-reduction is permitted. CHOP cycle delay is also permitted.
- The patient must be enrolled within 56 days of the first day of the last cycle of CHOP chemotherapy and within 35 days following response evaluation after CHOP chemotherapy.
- Patients must have evidence that their tumor tissue expresses the CD20 antigen.
- Patients must have a performance status of at least 60% on the Karnofsky Performance Scale and an anticipated survival of at least 3 months.
- Patients must have an ANC greater than or equal to 1500 cells/mm3 and a platelet count greater than or equal to 100,000 cells/mm3 within 14 days of study enrollment. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
- Patients must have adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal) and hepatic function (defined as total bilirubin less than or equal to 2.0 times the upper limit of normal and AST <5 times the upper limit of normal) within 20 days of study enrollment.
- Patients of childbearing potential must undergo a negative serum pregnancy test within 14 days prior to study enrollment
Exclusion Criteria:
- Patients who have received prior chemotherapy other than first-line CHOP. Patients must not have been treated with radiation, or biological therapy prior to or after CHOP chemotherapy.
- Patients with active bilateral obstructive hydronephrosis.
- Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
- Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. Patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study enrollment to rule out recurrent disease.
- Patients with known HIV infection.
- Patients who are HAMA positive.
- Patients with known brain or leptomeningeal metastases at any time since diagnosis.
- Patients with active infection requiring IV anti-infectives at the time of study enrollment.
- Patients who are pregnant or breastfeeding. Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1 Antibody.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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)
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2000年1月1日
研究注册日期
首次提交
2001年8月16日
首先提交符合 QC 标准的
2001年8月17日
首次发布 (估计)
2001年8月20日
研究记录更新
最后更新发布 (估计)
2005年6月24日
上次提交的符合 QC 标准的更新
2005年6月23日
最后验证
2004年9月1日
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.
非霍奇金淋巴瘤的临床试验
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Rutgers, The State University of New Jersey完全的
碘 131 抗 B1 抗体的临床试验
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GlaxoSmithKline完全的
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GlaxoSmithKline完全的
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)完全的粘膜相关淋巴组织结外边缘区B细胞淋巴瘤 | 淋巴结边缘区 B 细胞淋巴瘤 | 复发性成人伯基特淋巴瘤 | 复发性成人弥漫性大细胞淋巴瘤 | 复发性成人弥漫性混合细胞淋巴瘤 | 复发性成人弥漫性小裂细胞淋巴瘤 | 复发性成人免疫母细胞大细胞淋巴瘤 | 复发性成人淋巴母细胞淋巴瘤 | 复发性 1 级滤泡性淋巴瘤 | 复发性 2 级滤泡性淋巴瘤 | 复发性 3 级滤泡性淋巴瘤 | 复发性套细胞淋巴瘤 | 复发性边缘区淋巴瘤 | 脾边缘区淋巴瘤 | 华氏巨球蛋白血症美国
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University of NebraskaNational Cancer Institute (NCI); Coulter Pharmaceutical, Inc.终止
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Corixa CorporationGlaxoSmithKline未知
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Corixa CorporationGlaxoSmithKline未知