权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

City of Hope Core Clinical Center for the Blood and Marrow Transplant Clinical Trials Network

希望之城血液和骨髓移植临床试验网络核心临床中心

基本信息

批准号：
10657661
负责人：
RYOTARO NAKAMURA
金额：
$ 20.76万
依托单位：
BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-09-30 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10657661
关键词：
AIDS-Related Lymphoma Address Adjuvant Affect Allogenic Antiviral Agents Antiviral Therapy Applications Grants Area Autologous Basic Science Blood Bone Marrow Bone Marrow Transplantation CD8-Positive T-Lymphocytes California Cell Therapy Childhood Cities Clinic Clinical Clinical Research Clinical Trials Clinical Trials Network Collaborations Committee Members Complication Cyclic GMP Cytomegalovirus Cytomegalovirus Infections Cytomegalovirus Vaccines DNA Development Disease Disease-Free Survival Double-Blind Method Early Diagnosis Ensure Epitopes Faculty Funding Future Goals Grant HIV HLA A*0201 antigen Hematologic Neoplasms Hematological Disease Hematopoietic Stem Cell Transplantation Infection Institution Kidney Laboratories Laboratory Research Leadership Licensing Malignant - descriptor Morbidity - disease rate Multicenter Trials Multiple Myeloma Non-Malignant Non-Neoplastic Hematologic and Lymphocytic Disorder Organ Outcomes Research Patients Pediatric Research Peptides Pharmaceutical Preparations Phase Phase III Clinical Trials Phase Ib Trial Placebo Control Placebos Prevention Process Production Protocols documentation Qualifying Quality of life Randomized Regimen Request for Applications Research Research Personnel Review Committee Risk Safety Schedule Signal Transduction Source T-Lymphocyte T-Lymphocyte Epitopes Tetanus Therapeutic Research Toxic effect Transfusion Translational Research Transplant Recipients Vaccines Work arm care costs clinical center clinical development disorder control efficacy evaluation experience graft vs host disease healthy volunteer hematopoietic cell transplantation immune reconstitution immunogenicity improved improved outcome inpatient service investigator-initiated trial laboratory development manufacture manufacturing facility meetings member mortality novel phase II trial phase III trial programs prospective protocol development randomized trial safety study standard of care survivorship transplant centers transplantation therapy

项目摘要

PROJECT SUMMARY This grant application seeks to renew our status as a Core Clinical Center and member of the Steering Committee of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The City of Hope Hematopoietic Cell Transplantation Program has focused its efforts over the last 40 years on the development of laboratory-based translational research and Phase I, II and III clinical trials leading to improvements in hematopoietic cell transplantation (HCT) for the treatment of malignant and non-malignant hematologic disorders. During our 15 years as a member of the BMT CTN, we have participated in the development of clinical trials focused on important questions confronting HCT patients, several of which were derived from early phase studies conducted in our program. Many of our faculty members significantly contributed to the successful conduct of the BMT CTN trials and will continue to collectively work toward the common goal of improving outcomes of HCT. As the largest and oldest HCT center in California we offer unique and highly qualified capabilities for accruing diverse patients and supporting multi-center HCT trials, including cellular therapeutics. City of Hope has a longstanding research focus on cytomegalovirus (CMV), the most significant infectious complication post-HCT, addressing the unmet need to improve the current shortfalls of anti-viral drug-based approaches. Our laboratory collaborators have developed and manufactured a CMV vaccine (CMVPepVax) utilizing the HLA A*0201 pp65495-503 CD8+ T cell epitope fused to a universal TH epitope (a natural Tetanus sequence) that is co-injected with the CpG adjuvant PF-03512676. This vaccine has demonstrated safety and immunogenicity in a phase Ib trial of healthy volunteers and in HCT recipients, with promising efficacy signals in reducing CMV reactivation. The placebo-controlled randomized phase II trial of CMVPepVax is currently underway and accruing well. As part of this application we propose that the BMT CTN, in collaboration with City of Hope and the license holder Helocyte, conducts a prospective Phase III randomized, double-blind, multi- center trial of CMVPepVax versus placebo in patients receiving HCT from matched related or unrelated donors. Our study hypothesis is that use of CMVPepVax on days 28 and 56 post-HCT will improve the 12-month CMV- free survival in the vaccine arm compared to the placebo arm.

项目摘要此拨款申请旨在更新我们作为核心临床中心和指导成员的地位血液和骨髓移植临床试验网络委员会（BMT CTN）。希望之城造血细胞移植计划在过去的40年里一直致力于发展基于实验室的转化研究和I、II、III期临床试验，造血细胞移植（HCT）用于治疗恶性和非恶性血液病紊乱在我们作为BMT CTN成员的15年中，我们参与了临床试验集中在HCT患者面临的重要问题，其中一些来自早期阶段在我们的计划中进行的研究。我们的许多教师都为成功做出了重大贡献。进行BMT CTN试验，并将继续共同努力，以实现改善 HCT的结果。作为加州最大和最古老的HCT中心，我们提供独特和高质量的能够招募不同的患者并支持多中心HCT试验，包括细胞疗法。 City of Hope长期以来一直专注于巨细胞病毒（CMV）的研究， HCT后并发症，解决了改善目前基于抗病毒药物的接近。我们的实验室合作者已经开发和制造了CMV疫苗（CMVPepVax）利用与通用TH表位（天然破伤风抗原）融合的HLA A*0201 pp 65495 -503 CD 8 + T细胞表位序列），其与CpG佐剂PF-03512676共注射。该疫苗已被证明安全，在健康志愿者和HCT接受者的Ib期试验中，减少CMV再活化。CMVPepVax的安慰剂对照随机II期试验目前正在进行中。正在进行中，进展顺利。作为这项申请的一部分，我们建议BMT CTN与城市合作，的希望和许可证保持器Helocyte，进行了前瞻性III期随机，双盲，多- 在接受来自匹配的相关或无关供体的HCT的患者中比较CMVPepVax与安慰剂的中心试验。我们的研究假设是，在HCT后第28天和第56天使用CMVPepVax将改善12个月的CMV- 与安慰剂组相比，疫苗组的自由生存期。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Role of reduced intensity transplant in adult patients with acute lymphoblastic leukemia: If and when?

降低强度移植对成人急性淋巴细胞白血病患者的作用：是否以及何时？

DOI：
10.1016/j.beha.2009.10.006
发表时间：
2009
期刊：
Best practice & research. Clinical haematology
影响因子：
0
作者：
Forman,StephenJ
通讯作者：
Forman,StephenJ

Outcomes of Patients with Recurrent and Refractory Lymphoma Undergoing Allogeneic Hematopoietic Cell Transplantation with BEAM Conditioning and Sirolimus- and Tacrolimus-Based GVHD Prophylaxis.

复发性难治性淋巴瘤患者接受同种异体造血细胞移植、BEAM 调理以及基于西罗莫司和他克莫司的 GVHD 预防的结果。

DOI：
10.1016/j.bbmt.2018.09.009
发表时间：
2019
期刊：
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
影响因子：
0
作者：
Salhotra,Amandeep;Mei,Matthew;Stiller,Tracey;Mokhtari,Sally;Herrera,AlexF;Chen,Robert;Popplewell,Leslie;Zain,Jasmine;Ali,Haris;Sandhu,Karamjeet;Budde,Elizabeth;Nademanee,Auayporn;Forman,StephenJ;Nakamura,Ryotaro
通讯作者：
Nakamura,Ryotaro

Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma.