ETIB Clinical Research Core

ETIB 临床研究核心

• 批准号: 9344213
• 负责人: Ronald Gress
• 金额: $ 152.76万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9344213
• 关键词: Age; Allogenic; Area; Assessment tool; Autoimmune Diseases; Autoimmune Process; Autoimmunity; Basic Science; Biological Response Modifiers; Biology; Blood; Bone Marrow; Bone Marrow Transplantation; Cancer Vaccines; Caring; Cause of Death; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Communicable Diseases; Communities; Consensus; Data Analyses; Data Collection; Dentistry; Dermatology; Discipline; Disease; Doctor of Medicine; Dose; Educational workshop; Enrollment; Evaluation; Exposure to; Extramural Activities; Fellowship; Foundations; Geum; Goals; Guidelines; Gynecology; HIV; Head; Hematology; Hematopoietic Stem Cell Transplantation; Hodgkin Disease; Homologous Transplantation; Human; Immune; Immunity; Immunocompromised Host; Immunology; Immunotherapy; Individual; Infection; Institutes; Interleukin-2; Interleukin-7; International; Investigation; Joints; Laboratories; Leadership; Lymph; Lymphoma; Malignant Neoplasms; Marrow; Measurement; Multiple Myeloma; National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Disease; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Child Health and Human Development; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Hematologic Malignancy; Non-Hodgkin' s Lymphoma; Oncologist; Ophthalmology; Oral Surgical Procedures; Organ Transplantation; Pain; Palliative Care; Pathologic; Patient Care; Patient Recruitments; Patients; Pediatric Oncology; Phase; Physical Medicine; Physiological; Pilot Projects; Policies; Population; Property; Protocols documentation; Pulmonology; Refractory; Regenerative Medicine; Regimen; Rejuvenation; Relapse; Renal carcinoma; Research; Research Activity; Research Infrastructure; Research Personnel; Rheumatology; Scientist; Series; Societies; Source; Stem Cell Research; Support Groups; T-Lymphocyte; Toxic effect; Translational Research; Transplant Recipients; Transplantation; United States National Institutes of Health; Work; base; cancer site; cancer therapy; career development; chemotherapy; chronic graft versus host disease; clinical care; cytokine; design; disease mechanisms study; graft vs host disease; immunoregulation; interest; leukemia; medical specialties; member; multidisciplinary; novel strategies; oncology; patient population; programs; reconstitution

The Experimental Transplantation and Immunology Branch (ETIB) clinical transplantation program has as goals the cure of cancer through hematopoietic stem cell transplant therapies, conducting outstanding translational research, and providing the highest level of excellence in clinical care. To this end, the Clinical Core of ETIB was developed. The ETIB Clinical Core provides interactions, activities and support across the branch. It represents a collection of individuals each with particular expertise in clinical transplantation and clinical research. While the section functions as a coordinated effort, it is also designed for individual career development and professional advancement for members. Specific aims include developing a supportive infrastructure for the conduct of clinical transplantation trials, establishing consistent clinical policies and practices in the care of transplantation patients in order to achieve excellence in clinical care, and providing and promoting educational opportunities in hematopoietic stem cell transplantation. Dr. Ronald Gress heads the Immunotherapy Unit of the core. Current research activities center on cancer vaccines in the setting of immune reconstitution following dose intensive chemotherapy. He also has interests in modulation of immune reconstitution by cytokines; he, in collaboration with POB, headed the trial to introduce IL-7 into formal phase 1 evaluation. This study was designed and executed as a phase I, inter-patient dose escalation study. It sought to characterize the immunobiologic effects of rhIL-7 therapy in humans and, in particular, its potential for immune rejuvenation of T cell sub-populations. Sixteen subjects with non-hematologic cancer refractory to standard therapy were enrolled (National Cancer Institute, protocol 03-C-0152). RhIL-7 was an effective and well tolerated T cell growth factor with immune rejuvenating properties that suggested it would be effective in augmenting immune reactivity in patients with impaired immunity due to physiologic (age), iatrogenic (chemotherapy/ transplantation) or pathologic (HIV) lymphodepletion. Dr. Juan Gea-Banacloche heads the Infectious Disease Unit of the core. Infections are second only to relapse of malignancy as a cause of death after allogeneic transplant. Excellence in the management of infectious diseases is thus of the utmost importance in establishing a successful transplant program. Over the past 8 years, Dr. Gea-Banacloche has provided constant clinical care of the infectious diseases complications of patients registered on the transplant protocols of ETIB. Dr. Gea-Banacloche has been the source of clinical standards for the management of blood and marrow transplants in the Clinical Center. He has been the main architect of an inter-institute collaboration (NCI-NIAID-NHLBI) that has resulted in the NIH Clinical Center Guidelines for Infection Management of Hematopoietic Stem Cell Transplant Recipients. As part of the collaboration between NCI and NIAID, Dr. Gea-Banacloche has been instrumental in creating a fellowship in "Infectious Disease in Immunocompromised Hosts", which will allow candidates with a background in Infectious Diseases, Hematology-Oncology and other disciplines in-depth exposure to the unique patient populations seen at the NIH Clinical Center as well as introduction to clinical or translational research. Dr. Steven Pavletic, M.D., is head of the GVHD and Autoimmunity Unit. The focus of the autoimmunity program is to study disease mechanisms that separate self-destructive autoimmunity from potentially beneficial autoimmune effects relevant to the treatment of cancer. In January 2003, Dr. Pavletic established an ETIB inter-institute cGVHD program to include a multidisciplinary clinic which brings together clinicians and scientists from eight NIH institutes (NCI, NIAID, NHLBI, NIAMS, NEI, NIDDK, NICHD, NIDCR) and the Clinical Center. The cGVHD clinic serves as a foundation for providing better care of patients and to study cGVHD. The clinic involves clinical researchers of various specialties such as hematology-oncology, pediatric oncology, ophthalmology, dermatology, rheumatology, rehabilitation medicine, pain and palliative care, gynecology, pulmonology, dentistry, oral surgery and others. Multiple laboratories are involved in basic science investigations in protocols based in the clinic. Key objectives of this interdisciplinary clinic-based program include developing new and better chronic GVHD assessment tools to standardize disease measurements in clinical trials, studying chronic GVHD biology, and developing new treatments for chronic GVHD. Dr. Pavletic has also organized efforts in cGVHD at other levels: Local leadership with a joint annual NIH/John Hopkins scientific workshop on cGVHD (held in May 2003 and 2004), regional leadership with formation of the Mid-Atlantic cGVHD consortium comprised of bone marrow transplanters and community oncologists in the region, establishment of a cGVHD patient support group with the DC Leukemia Society Chapter, and national/international leadership with formation of a group to formulate NIH consensus criteria for clinical trials in cGVHD. In collaboration with the extramural office at NIAID and national and international colleagues, Dr. Pavletic initiated a series of three expert workshops to explore pilot studies of allogeneic HSCT in patients with severe autoimmune disease. These three workshops were held in March 2005 (Bethesda) Exploring the feasibility of allogeneic transplantation for autoimmune disease; October 2005 (Newport Beach) Determining the best patient populations and October 2006 (Bethesda) Determining best transplant regimens and disease-specific toxicity issues. These works have been extensively cited since then, forming a basis for invigorating and standardizing the field. Dr. Hardy initiated a similar effort in the area of relapse post transplant. This has resulted in an increased interest in developing new approaches for overcoming this barrier to allogeneic hematopoietic stem cell transplantation, and emphasized the importance of maintaining a focus on this area within the field. Relevant cancer sites: Hodgkins Disease/Lymphoma, Non-Hodgkins Lymphoma, Multiple Myeloma, Kidney Cancer. Relevant Research Areas: Stem Cell Research, Biological Response Modifiers, Bone Marrow Transplantation, Autoimmune Disease, Immunology, Hematology/Lymph, Regenerative Medicine, Organ Transplantation Research, Clinical Research.

实验移植和免疫学分支 (ETIB) 临床移植项目的目标是通过造血干细胞移植疗法治愈癌症，开展杰出的转化研究，并提供最高水平的卓越临床护理。为此，开发了 ETIB 的临床核心。 ETIB 临床核心提供整个分支机构的互动、活动和支持。它代表了一群在临床移植和临床研究方面具有特定专业知识的个人。虽然该部门作为一项协调工作发挥作用，但它也是为会员的个人职业发展和专业进步而设计的。具体目标包括为临床移植试验的开展建立支持性基础设施，在移植患者的护理方面建立一致的临床政策和实践，以实现卓越的临床护理，以及提供和促进造血干细胞移植的教育机会。 Ronald Gress 博士领导核心免疫治疗部门。目前的研究活动集中在剂量密集化疗后免疫重建中的癌症疫苗。他还对细胞因子调节免疫重建感兴趣。他与 POB 合作，领导了将 IL-7 引入正式第一阶段评估的试验。该研究是作为 I 期患者间剂量递增研究而设计和执行的。它试图表征 rhIL-7 疗法对人类的免疫生物学作用，特别是其对 T 细胞亚群免疫复兴的潜力。招募了 16 名患有标准治疗难治性非血液癌症的受试者（国家癌症研究所，方案 03-C-0152）。 RhIL-7 是一种有效且耐受性良好的 T 细胞生长因子，具有免疫恢复特性，这表明它可以有效增强因生理（年龄）、医源性（化疗/移植）或病理性 (HIV) 淋巴细胞清除而导致免疫力受损的患者的免疫反应性。 Juan Gea-Banacloche 博士是核心传染病科的负责人。感染是同种异体移植后仅次于恶性肿瘤复发的第二大死亡原因。因此，卓越的传染病管理对于建立成功的移植计划至关重要。在过去的 8 年里，Gea-Banacloche 医生一直为 ETIB 移植方案上登记的患者的传染病并发症提供持续的临床护理。 Gea-Banacloche 博士一直是临床中心血液和骨髓移植管理临床标准的制定者。他是机构间合作 (NCI-NIAID-NHLBI) 的主要架构师，该合作制定了 NIH 临床中心造血干细胞移植受者感染管理指南。作为 NCI 和 NIAID 合作的一部分，Gea-Banacloche 博士在创建“免疫功能低下宿主的传染病”奖学金方面发挥了重要作用，该奖学金将使具有传染病、血液肿瘤学和其他学科背景的候选人深入接触 NIH 临床中心看到的独特患者群体，并介绍临床或转化研究。 Steven Pavletic 博士，医学博士，是 GVHD 和自身免疫科的负责人。自身免疫项目的重点是研究将自我破坏性自身免疫与与癌症治疗相关的潜在有益自身免疫效应分开的疾病机制。 2003 年 1 月，Pavletic 博士建立了 ETIB 机构间 cGVHD 计划，其中包括一个多学科诊所，该诊所汇集了来自 8 个 NIH 机构（NCI、NIAID、NHLBI、NIAMS、NEI、NIDDK、NICHD、NIDCR）和临床中心的临床医生和科学家。 cGVHD 诊所是为患者提供更好的护理和研究 cGVHD 的基础。该诊所涉及血液肿瘤学、儿科肿瘤学、眼科、皮肤科、风湿病学、康复医学、疼痛和姑息治疗、妇科、肺科、牙科、口腔外科等多个专业的临床研究人员。多个实验室根据临床方案参与基础科学研究。这个跨学科的临床项目的主要目标包括开发新的、更好的慢性 GVHD 评估工具，以标准化临床试验中的疾病测量、研究慢性 GVHD 生物学以及开发慢性 GVHD 的新疗法。 Pavletic 博士还在其他层面组织了 cGVHD 方面的工作：通过 NIH/约翰·霍普金斯联合举办的年度 cGVHD 科学研讨会（2003 年 5 月和 2004 年举行）作为地方领导，通过组建由该地区的骨髓移植者和社区肿瘤学家组成的中大西洋 cGVHD 联盟进行区域领导，与 DC 白血病建立 cGVHD 患者支持小组 协会分会和国家/国际领导层组建了一个小组来制定 NIH 的 cGVHD 临床试验共识标准。 Pavletic 博士与 NIAID 校外办公室以及国内外同事合作，发起了一系列三场专家研讨会，探索对严重自身免疫性疾病患者进行同种异体 HSCT 的试点研究。这三个研讨会于2005年3月举行（Bethesda），探讨同种异体移植治疗自身免疫性疾病的可行性； 2005 年 10 月（纽波特海滩）确定最佳患者群体，2006 年 10 月（贝塞斯达）确定最​​佳移植方案和疾病特异性毒性问题。从那时起，这些著作被广泛引用，为振兴和规范该领域奠定了基础。哈迪博士在移植后复发领域发起了类似的努力。这导致人们越来越有兴趣开发新方法来克服同种异体造血干细胞移植的这一障碍，并强调了在该领域保持关注这一领域的重要性。相关癌症部位：霍奇金病/淋巴瘤、非霍奇金淋巴瘤、多发性骨髓瘤、肾癌。相关研究领域：干细胞研究、生物反应调节剂、骨髓移植、自身免疫性疾病、免疫学、血液/淋巴、再生医学、器官移植研究、临床研究。