CLINICAL TRIAL: A PILOT STUDY OF YTTRIUM-90-LABELED ANTI-CD20 MONOCLONAL

临床试验：钇 90 标记的抗 CD20 单克隆抗体的试点研究

• 批准号: 7716636
• 负责人: AMRITA KRISHNAN
• 金额: $ 0.12万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716636
• 关键词: 90Y; Aftercare; Antibodies; Ara-C; Autologous; Autologous Stem Cell Transplantation; Autologous Transplantation; B-Cell Lymphomas; B-Lymphocytes; Blood Cells; Carmustine; Carmustine/Cytarabine/Etoposide/Melphalan; Cells; Clinical; Clinical Trials; Collection; Computer Retrieval of Information on Scientific Projects Database; Diagnosis; Disease; Disease remission; Dose; Drug resistance; Effectiveness; Etoposide; Funding; Grant; High Dose Chemotherapy; Infection; Institution; Label; Length; Leukocytes; Lymphoma; Malignant Neoplasms; Melphalan; Monoclonal Antibody IDEC-C2B8; Murine Monoclonal Antibody 2B8; No Evidence of Disease; Non-Hodgkin' s Lymphoma; Patients; Pharmaceutical Preparations; Pilot Projects; Preparation; Purpose; Radiation; Radiation therapy; Radioactive; Relapse; Research; Research Personnel; Resources; Roche brand of rituximab; Safety; Site; Source; Standards of Weights and Measures; Stem cell transplant; Stem cells; Testing; Treatment Protocols; United States National Institutes of Health; Veins; Yttrium; chemotherapy; fighting; response; rituximab; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purposes of this study are to 1> evaluate the safety and effectiveness of a treatment regimen using an antibody attached to a radioactive substance (IDEC-Y2B8) in combination with high-dose chemotherapy (with the drugs BCNU, Etoposide, Ara-C and Melphalan, or BEAM) followed by autologous stem cell transplant (ASCT); and 2> to evaluate the short-term and long-term complications of this regimen in patients diagnosed with non-Hodgkin's lymphoma. Non-Hodgkin's lymphoma is a malignancy of B lymphocytes, which are the white blood cells that normally make antibodies that help fight infections. Although remission (no evidence of disease by standard clinical tests) can occur with conventional chemotherapy and/or radiation therapy, the length of remission is usually short and relapses (return of disease) occur. The outlook for patients with relapsed lymphoma is poor. Recent studies have shown that intensive, high-dose chemotherapy followed by autologous stem cell transplantation (ASCT), can produce long-term remission in patients with relapsed lymphoma. BEAM is one of the most commonly used high-dose regimens for preparation of ASCT. ASCT involves collection of the subject's stem cells (immature cells that can become blood cells) before therapy and return of these cells to the subject (through a vein) after therapy is over. However, relapses also occur with this treatment regimen. The antibody, Rituximab (Rituxan or IDEC-C2B8) has been shown to produce remission in about half of the B-cell lymphoma subjects treated. In previous studies, this antibody has been shown to selectively locate and destroy B-cells, including B-cell lymphoma, and to cause drug-resistant lymphoma cells to become sensitive to chemotherapy. Adding a radioactive substance called Yttrium to IDEC-Y2B8, (creating a radioactive combination called IDEC-Y2B8) allows radiation to be carried directly to tumor sites which can increase the anti-tumor effect. In a past study of IDEC-Y2B8, about two-thirds of the subjects with B-cell lymphoma had shown greater than 50% shrinkage of the tumor after treatment and in one-fourth of them all the tumor was gone. The duration of response was about 12 months. The present study will use intensive, high-dose chemotherapy (BEAM) and IDEC-Y2B8, followed by ASCT. This study will try to determine the safety and effectiveness of this combination regimen.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是1>评估使用附着于放射性物质的抗体的治疗方案的安全性和有效性（IDEC-Y2 B8）联合高剂量化疗（用药物BCNU、依托泊苷、阿糖胞苷和美法仑或BEAM），然后进行自体干细胞移植（ASCT）; 2、评价该方案治疗非霍奇金淋巴瘤的近期和远期并发症。 非霍奇金淋巴瘤是一种恶性肿瘤的B淋巴细胞，这是白色血细胞，通常使抗体，帮助打击感染。虽然缓解（通过标准临床试验没有疾病的证据）可以用常规化疗和/或放疗发生，但缓解的时间通常很短，并且会发生复发（疾病复发）。复发性淋巴瘤患者的前景很差。最近的研究表明，强化，高剂量化疗后自体干细胞移植（ASCT），可以产生长期缓解复发性淋巴瘤患者。BEAM是制备ASCT最常用的高剂量方案之一。ASCT涉及在治疗前收集受试者的干细胞（可以成为血细胞的未成熟细胞），并在治疗结束后将这些细胞返回受试者（通过静脉）。然而，这种治疗方案也会出现复发。抗体利妥昔单抗（Rituxan或IDEC-C2 B8）已被证明在约一半的B细胞淋巴瘤受试者中产生缓解。在以前的研究中，这种抗体已被证明可以选择性地定位和破坏B细胞，包括B细胞淋巴瘤，并导致耐药淋巴瘤细胞对化疗敏感。在IDEC-Y2 B8中加入一种名为钇的放射性物质（产生一种名为IDEC-Y2 B8的放射性组合），使辐射直接到达肿瘤部位，从而增加抗肿瘤作用。在过去的IDEC-Y2 B8研究中，约三分之二的B细胞淋巴瘤受试者在治疗后肿瘤缩小超过50%，其中四分之一的受试者肿瘤全部消失。反应持续时间约为12个月。本研究将使用强化、高剂量化疗（BEAM）和IDEC-Y2 B8，然后进行ASCT。本研究将尝试确定这种联合方案的安全性和有效性。