A PILOT STUDY OF YTTRIUM-90-LABELED ANTI-CD20 MONOCLONAL

钇90标记的抗CD20单克隆抗体的初步研究

• 批准号: 7603867
• 负责人: AMRITA KRISHNAN
• 金额: $ 0.39万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603867
• 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; 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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是 1> 评估使用附有放射性物质的抗体 (IDEC-Y2B8) 与高剂量化疗（药物 BCNU、依托泊苷、Ara-C 和美法仑 (Melphalan)，或 BEAM)，随后进行自体干细胞移植 (ASCT)； 2> 评估该方案在诊断为非霍奇金淋巴瘤的患者中的短期和长期并发症。 非霍奇金淋巴瘤是 B 淋巴细胞的恶性肿瘤，B 淋巴细胞是通常产生有助于抵抗感染的抗体的白细胞。虽然常规化疗和/或放疗可以缓解（标准临床测试没有疾病证据），但缓解期通常很短，并且会出现复发（疾病复发）。复发性淋巴瘤患者的前景不佳。最近的研究表明，强化、高剂量化疗后进行自体干细胞移植（ASCT）可以使复发性淋巴瘤患者获得长期缓解。 BEAM 是准备 ASCT 时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（可以变成血细胞的未成熟细胞），并在治疗结束后将这些细胞（通过静脉）返回受试者体内。然而，这种治疗方案也会出现复发。抗体 Rituximab（Rituxan 或 IDEC-C2B8）已被证明可以使大约一半的 B 细胞淋巴瘤受试者得到缓解。在之前的研究中，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变得敏感。在IDEC-Y2B8中添加一种名为钇的放射性物质（创建一种名为IDEC-Y2B8的放射性组合），可以将辐射直接传送到肿瘤部位，从而增强抗肿瘤效果。在 IDEC-Y2B8 过去的一项研究中，大约三分之二的 B 细胞淋巴瘤受试者在治疗后显示肿瘤缩小了 50% 以上，其中四分之一的肿瘤全部消失。响应持续时间约为12个月。本研究将使用强化、高剂量化疗 (BEAM) 和 IDEC-Y2B8，然后进行 ASCT。这项研究将试图确定这种联合治疗方案的安全性和有效性。