BRYOSTATIN 1 + VINCRISTINE IN NON-HODGKIN'S LYMPHOMA POST TRANSPLANT

苔藓抑素 1 长春新碱在非霍奇金淋巴瘤移植后的应用

• 批准号: 7378048
• 负责人: Scot C Remick
• 金额: $ 0.55万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378048
• 关键词: BRYOSTATIN; VINCRISTINE; NON; HODGKIN; LYMPHOMA

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 objectives of this study are: 1) to evaluate the response rate when bryostatin 1 is given in combination with vincristine in patients with low and intermediate grade non-Hodgkin's lymphoma who have progressed or relapsed following an autologous bone marrow or stem cell transplant, 2) to determine if blunting of apoptotic response at 6 hours of treatment using annexin V staining of peripheral blood CD5+ and CD19+ lymphocytes by flow cytometry is predictive of outcome (i.e. lack of clinical response), and 3) to prospectively evaluate the incidence of greater than or equal to grade 3 myelotoxicity with this regimen. Subjects will receive bryostatin-1 by vein continuously over 24 hours followed by vincristine given by vein over 5 minutes. This treatment will be repeated every two weeks. Two 2-week treatment periods make up one cycle (28 days). Subjects may receive up to six cycles of therapy. If responsive, patient may then switch to a treatment once every 3 weeks and continue on therapy unless there is disease progression or a lack of response. Subjects will stay at the GCRC only on Cycle 1, Day 1 for medication administration and blood draws at 0, 6, 24 and 30 hours. The study will enroll approximately 28 subjects at four sites (about 15 subjects at this site).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是：1）评估苔藓抑素1与长春新碱联合给药在自体骨髓或干细胞移植后进展或复发的低度和中度非霍奇金淋巴瘤患者中的应答率，2）使用外周血CD 5+和CD 19+的膜联蛋白V染色来确定在处理6小时时凋亡应答是否钝化通过流式细胞术检测淋巴细胞数量可预测结果（即缺乏临床应答），和3）前瞻性评估该方案大于或等于3级骨髓毒性的发生率。受试者将在24小时内连续静脉接受苔藓抑素-1，随后在5分钟内静脉给予长春新碱。这种治疗将每两周重复一次。两个2周治疗期构成一个周期（28天）。受试者可接受最多6个周期的治疗。如果有反应，患者可以每3周一次转换为治疗，并继续治疗，除非疾病进展或缺乏反应。受试者仅在周期1第1天留在GCRC接受给药，并在0、6、24和30小时抽血。本研究将在4个研究中心入组约28例受试者（本研究中心约15例受试者）。