Hematopoietic stem cell (HCT) transplantation offers curative therapy for a variety of malignant and non- malignant disorders. It is limited by donor availability, transplant related toxicity, graft vs. host disease (GVHD), malignant relapse, infections, and for some patients, reduction in their post-transplant quality of life. Continuing progress from the previous funding period, the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) proposes to develop and execute scientifically meritorious, prospective clinical trials addressing key issues in HCT. Due to the complexity of pediatric transplantation, especially in those with rare inherited disorders, which are complex and difficult to study, we will devote special attention and focused scientific expertise to using the coordinated strength of the Network to improve BMT outcomes for this unique population. The BMT CTN will also amplify and leverage Network resources through collaborative research and ancillary studies of biologic endpoints that will be integrated with and complement clinical endpoints. The Network will also seek active collaboration with other scientific bodies including NCI- funded Cancer Cooperative Groups to improve the efficiency of clinical transplant studies for the large number of patients who could benefit from BMT and to maximize our successful completion of high quality and high priority clinical trials. The Fred Hutchinson Cancer Research Center is an ideal site to conduct multicenter Phase II and more importantly, prospective Phase III trials in six key areas including: alternative donors and graft sources;regimen related toxicity;GVHD;disease recurrence;infection and immune reconstitution;and late effects and quality of life. The Center is deeply committed to cooperative clinical research and can provide an outstanding environment in which to conduct the sorts of studies described with state-of-the-art clinical and laboratory facilities.

Public Health Relevance

The major barriers to clinical studies in HSCT include the heterogeneity of conditions, the small numbers of individuals with an indication for HSCT at any one center, the differences in treatment strategies at various centers, and the lack of resources to coordinate national collaborative efforts. The Blood &Marrow Clinical Trial Network uses a multicenter approach to effectively conduct clinical trials of novel therapies in patients with uncommon conditions.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10HL069246-11
Application #
8174394
Study Section
Special Emphasis Panel (ZHL1-CSR-K (M3))
Program Officer
Di Fronzo, Nancy L
Project Start
2002-06-05
Project End
2017-06-30
Budget Start
2011-08-08
Budget End
2012-06-30
Support Year
11
Fiscal Year
2011
Total Cost
$174,240
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Wingard, John R; Wood, William A; Martens, Michael et al. (2017) Pretransplantation Exercise and Hematopoietic Cell Transplantation Survival: A Secondary Analysis of Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0902). Biol Blood Marrow Transplant 23:161-164
Syrjala, Karen L; Sutton, Steven K; Jim, Heather S L et al. (2017) Cancer and treatment distress psychometric evaluation over time: A BMT CTN 0902 secondary analysis. Cancer 123:1416-1423
Wood, William A; Le-Rademacher, Jennifer; Syrjala, Karen L et al. (2016) Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902). Cancer 122:91-8
Jim, Heather S L; Sutton, Steven K; Small, Brent J et al. (2016) Trajectories of Quality of Life after Hematopoietic Cell Transplantation: Secondary Analysis of Blood and Marrow Transplant Clinical Trials Network 0902 Data. Biol Blood Marrow Transplant 22:2077-2083
Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S et al. (2016) Patient-Reported Outcomes and Socioeconomic Status as Predictors of Clinical Outcomes after Hematopoietic Stem Cell Transplantation: A Study from the Blood and Marrow Transplant Clinical Trials Network 0902 Trial. Biol Blood Marrow Transplant 22:2256-2263
Appelbaum, Frederick R; Anasetti, Claudio; Antin, Joseph H et al. (2015) Blood and marrow transplant clinical trials network state of the Science Symposium 2014. Biol Blood Marrow Transplant 21:202-24
Khera, Nandita; Majhail, Navneet S; Brazauskas, Ruta et al. (2015) Comparison of Characteristics and Outcomes of Trial Participants and Nonparticipants: Example of Blood and Marrow Transplant Clinical Trials Network 0201 Trial. Biol Blood Marrow Transplant 21:1815-22
Anderlini, Paolo; Wu, Juan; Gersten, Iris et al. (2015) Cyclophosphamide conditioning in patients with severe aplastic anaemia given unrelated marrow transplantation: a phase 1-2 dose de-escalation study. Lancet Haematol 2:e367-75
Wagner Jr, John E; Eapen, Mary; Carter, Shelly et al. (2014) One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med 371:1685-94
Yanik, Gregory A; Horowitz, Mary M; Weisdorf, Daniel J et al. (2014) Randomized, double-blind, placebo-controlled trial of soluble tumor necrosis factor receptor: enbrel (etanercept) for the treatment of idiopathic pneumonia syndrome after allogeneic stem cell transplantation: blood and marrow transplant clinical trials ne Biol Blood Marrow Transplant 20:858-64

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