PATIENTS WITH STABLE OR PROGRESSIVE GRADE 1 OR 2 FOLLICULAR B-CELL LYMPHOMAS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项开放标签的单臂II期研究，旨在评估肿瘤特异性独特型蛋白偶联KLH(FavID)联合可溶性GM-CSF免疫佐剂对这名稳定性1或2级滤泡性B细胞淋巴瘤(WHO分级)的临床疗效。将跟踪患者的客观反应、进展时间、免疫反应和安全性。 将参与这一单一同情用途研究的患者接受了受累淋巴结活检，以获取组织进行形态分类、免疫表型表征，并为产生肿瘤特异性ID蛋白提供材料。 患者的病史如下： 1例53岁女性，1998年首次诊断为晚期滤泡性淋巴瘤。她的治疗史如下： 1998年使用8个周期的利妥昔单抗，随后进行观察。 2000年4月复发，用利妥昔单抗治疗4个周期。 2001年2月参加FavID-01试验，每周接受6周期美罗华治疗。 2001年5月对利妥昔单抗反应不足，退出FavID-01疫苗试验。 2001年6月接受PEP-C治疗3个月，病情稳定，随后接受氯氨丁苯治疗3个月。 2002年4月出现进展性疾病，接受了7个周期的氟达拉滨和米托蒽醌治疗，部分有效。 2003年4月，CHIP方案4个周期，有效率最低；吉西他滨、长春瑞滨、多西平治疗有效率最低。 2004年4月，用氟达拉滨和利妥昔单抗治疗，部分缓解。治疗因血细胞减少而停止。 2004年10月用每周8个周期的利妥昔单抗治疗。 2005年6月非成髓血型匹配的非血缘关系供者造血干细胞移植。 2005年9月PET/CT，骨髓无淋巴瘤的证据。 这位患者患有滤泡性B细胞淋巴瘤，将使用FavID-01方案中概述的相同剂量、治疗方案和监测进行治疗。这名患者要求接种为斯坦福大学FavID-01试验制造的疫苗。向FDA提交了允许交叉提交单个患者IND用于同情使用Favrille的IND的请求，BB-IND-8786，并获得批准。该协议得到了斯坦福IRB的批准。

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. This is an open-label, single-arm Phase II study designed to evaluate the clinical efficacy of immunotherapy with tumor-specific idiotype protein coupled to KLH (FavId) in combination with soluble GM-CSF immunoadjuvant in this patient with stable grade 1 or 2 follicular B-cell lymphoma (WHO classification). The patient will be followed for objective response, time to progression, immune response and safety. The patient who will participate in this single compassionate use study underwent an involved lymphnode biopsy to obtain tissue for morphological classification, immunophenotypic characterization and to provide material for generation of tumor specific Id protein. The patient's history is as follows: A 53-year-old woman initially diagnosed with advanced follicular Lymphoma in 1998. Her treatment history as follows: 1998 Eight cycles of rituximab, followed by observation. April 2000 Recurrent disease, treated with 4 cycles of rituximab. February 2001 Enrolled in FavId-01 trial, received 6 cycles weekly rituximab. May 2001 Inadequate response to rituximab, withdrew from FavId-01 vaccine trial. June 2001 Received PEP-C for 3 months with stable disease followed by chlorambucil for 3 months. April 2002 Developed progressive disease and was treated with seven cycles fludarabine and mitoxantrone with partial response. April 2003 Treated with 4 cycles CHOP with minimal response, received gemcitabine, navelbine, and Doxil with minimal response. April 2004 Treated with fludarabine and rituximab with partial response. Treatment stopped for low blood counts. October 2004 Treated with 8 cycles of weekly rituximab. June 2005 Non-myeloblative matched unrelated donor hematopoietic stem cell transplant. September 2005 PET/CT, no evidence of lymphoma on bone marrow. This patient has follicular B-cell lymphoma, and would be treated using the same dose, schedule and monitoring as outlined in protocol FavId-01. The patient has asked to receive the vaccine that was manufactured for the FavId-01 trial at Stanford. A request for permission to cross-file a Single Patient IND for Compassionate Use to Favrille's IND for FavId, BB-IND-8786 was submitted to the FDA and approval was granted. The protocol was approved by the Stanford IRB.