HEMATOLOGY

血液学

• 批准号: 6665606
• 负责人: Thomas E. Witzig
• 金额: $ 7.89万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-01-01 至 2002-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6665606
• 关键词: B cell lymphoma; blood tests; clinical research; cooperative study; hematology; human subject; myeloproliferative neoplasm; neoplastic cell

The accrual of NCCTG Hematology Group cancer treatment protocols to date has been 165 patients since January 1, 1996 with an average of 41 patients per year. An additional 162 patients have entered our randomized study of erythropoietin for anemic patients on chemotherapy. Eight studies have been activated during this time period, four have been completed, six are currently active, and six new protocols will be activated in early 2000. If all protocols that are currently are activated as planned by early 2000, we will have 12 NCCTG Hematology protocols open in 2000. The group has published one manuscript on the results of a CLL trial (93- 81-51) that tested chlorambucil and 2-CDA for patients with active, previously untreated disease (Tefferi et al., American Journal of Clinical Oncology 22(5):509-516, 1999). Dr. David Inwards recently presented at the annual meeting of the American of Hematology the results of NCCTG 95-80-53 which studied 2-CDA as initial treatment for previously untreated mantle cell lymphoma and these results are now published in abstract form (Blood 94 (10) Suppl 1 (660A), 1999). Several studies have met their targeted accrual, are closed, and are awaiting final analysis before submission in abstract and full manuscript form. Tumor cells from patients entering the NCCTG CLL trials have been used for ancillary laboratory investigations that have focused on cytogenetic abnormalities detected in tumor cells using fluorescence in situ investigations that have focused on cytogenetic abnormalities detected in tumor cells using fluorescence in situ hybridization (FISH) and detection of surface markers and adhesion molecules by flow cytometry. The results of our study of syndecan-1 (co-receptor for fibroblast growth factor) expression of malignant B-cells have been published (Leukemia and Lymphoma 31:1267-175, 1998). During the past two years, it has become apparent that the number of patients entering NCCTG Hematology protocols was too low. The primary reason for the inadequate accrual was a lack of open protocols rather than poor accrual to open studies. The small number of active studies was not anticipated and is due to several reasons: 1) some important pilot studies at the Mayo Clinic research base did not show adequate activity to warrant full NCCTG trials; 2) four approved trials have been able to open because of failure to obtain drug from pharmaceutical sponsors; 3) competition from ECOG has limited the number of protocols in multiple myeloma and acute leukemia. Interest on the part of the community hematologists remains high in support of NCCTG Hematology, because the protocols do indeed address tumor sites (such as CLL and NHL) that they see on a routine basis. Because of lack of accrual, it was recommended by External Advisory Group that Hematology not be included as a full program in the February, 2000, grant submission; however, Hematology will continue as a working group with the aim of activating all of the protocols in development by Spring, 2000. We then plan to resubmit an out-of-cycle request for financial support to the National Cancer Institute as a full program in 1-2 years. We have developed a plan to strengthen the NCCTG Hematology Program by 1) increasing the number of active protocols; 2) focusing our efforts on the B-cell malignancies, myelodysplastic syndromes, and myeloproliferative disorders; 3) increasing the FTE commitment to the Hematology Program; and 4) shortening the protocol development and activation time. We fully intend to establish a solid track record over the next few years which will justify submission for NCI support of an NCCTG Hematology Program.

自 1996 年 1 月 1 日以来，NCCTG 血液学组癌症治疗方案迄今已累计治疗 165 名患者，平均每年 41 名患者。另外 162 名患者参加了我们针对化疗贫血患者的促红细胞生成素随机研究。在此期间已启动了 8 项研究，其中 4 项已完成，6 项目前正在进行中，6 项新方案将于 2000 年初启动。如果目前所有方案在 2000 年初按计划启动，我们将拥有 12 个 NCCTG血液学方案于 2000 年开放。该小组发表了一份关于 CLL 试验 (93-81-51) 结果的手稿，该试验测试了苯丁酸氮芥和 2-CDA 对患有活动性、先前未治疗的疾病（Tefferi 等人，American Journal of Clinical Oncology 22(5):509-516, 1999）。 David Inwards 博士最近在美国血液学年会上介绍了 NCCTG 95-80-53 的结果，该研究研究 2-CDA 作为先前未治疗的套细胞淋巴瘤的初始治疗方法，这些结果现已以摘要形式发表（Blood 94） (10) 补编 1 (660A)，1999)。几项研究已达到其目标应计目标，已结束，正在等待最终分析，然后以摘要和完整手稿形式提交。进入 NCCTG C​​LL 试验的患者肿瘤细胞已用于辅助实验室研究，重点是使用荧光原位杂交 (FISH) 检测肿瘤细胞中的细胞遗传学异常，以及使用荧光原位杂交 (FISH) 检测肿瘤细胞中的细胞遗传学异常。通过流式细胞术检测表面标记和粘附分子。我们对恶性 B 细胞的 syndecan-1（成纤维细胞生长因子的辅助受体）表达的研究结果已发表（Leukemia and Lymphoma 31：1267-175，1998）。在过去两年中，加入 NCCTG 血液学方案的患者数量明显太少。应计费用不足的主要原因是缺乏开放协议，而不是开放研究的应计费用不佳。活跃研究数量较少是出乎意料的，原因如下：1）梅奥诊所研究基地的一些重要试点研究没有显示出足够的活动来保证全面的 NCCTG 试验； 2) 由于未能从制药申办者处获得药物，四项已获批准的试验得以开展； 3）来自ECOG的竞争限制了多发性骨髓瘤和急性白血病的治疗方案数量。社区血液学家对支持 NCCTG 血液学的兴趣仍然很高，因为该协议确实解决了他们在常规基础上看到的肿瘤部位（例如 CLL 和 NHL）。由于缺乏应计费用，外部咨询小组建议不要将血液学作为一个完整的项目纳入 2000 年 2 月的拨款申请中；然而，血液学将继续作为一个工作组，目标是在 2000 年春季之前启动所有正在开发的协议。然后，我们计划重新向国家癌症研究所提交一份周期外的财政支持请求，作为 2000 年的完整计划。 1-2年。我们制定了一项计划，通过以下方式加强 NCCTG 血液学计划： 1) 增加有效方案的数量； 2）重点关注B细胞恶性肿瘤、骨髓增生异常综合征和骨髓增生性疾病； 3) 增加对血液学项目的 FTE 承诺； 4) 缩短协议开发和激活时间。我们完全打算在未来几年内建立良好的记录，这将证明提交 NCI 对 NCCTG 血液学计划的支持是合理的。