Hematopoietic stem cell (HCT) transplantation offers curative therapy for a variety of malignant and nonmalignant disorders. It is limited by donor availability, transplant related toxicity, graft versus host disease, relapse of malignancy, infections, and for some patients, reduction in post-transplant quality of life. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) was established in 2001 to develop and execute scientifically meritorious, prospective clinical trials to address these issues. The Network has launched >20 trials with the support of a Data and Coordinating Center (DCC) comprised of a Consortium of the Center for International Blood and Marrow Transplant Research, the National Marrow Donor Program and The EMMES Corporation. The members of this DCC Consortium propose to continue supporting the Network and managing the efficient development, implementation and completion of high-quality Phase l-lll clinical trials for the Network, including concept evaluation and prioritization, protocol development with appropriate statistical designs, timely activation and accrual, monitoring for safety, compliance and data accuracy, and analyzing and disseminating results. The DCC Consortium will coordinate and support all BMT CTN activities maintaining a state-of-the-art database and systems for acquisition and storage of biologic specimens, ensuring data quality, laboratory compliance and adherence to regulatory requirements, managing contractual arrangements and fiscal activities, monitoring and improving center and overall Network performance and supporting all Network committees and activities with meeting planning and other logistical support. The Consortium will also help amplify and leverage Network resources through collaboration with other scientific bodies including National Cancer Institute-funded Cancer Cooperative Groups and the Stem Cell Therapeutic Outcomes Database to maximize successful completion of high quality and high priority clinical trials in HCT.

Public Health Relevance

The proposed Data and Coordinating Center (DCC) will support all activities of the BMT CTN, using the extensive expertise of the investigators in clinical research and transplantation. We will take advantage of collaborations with other organizations and initiatives to maximize efficiency and trial participation. The goal is to complete high quality clinical trials that focus on the most important barriers to transplant success.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL069294-13
Application #
8507794
Study Section
Special Emphasis Panel (ZHL1-CSR-K (M5))
Program Officer
Di Fronzo, Nancy L
Project Start
2001-09-30
Project End
2017-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
13
Fiscal Year
2013
Total Cost
$6,700,311
Indirect Cost
$311,250
Name
Medical College of Wisconsin
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
937639060
City
Milwaukee
State
WI
Country
United States
Zip Code
53226
Carpenter, Paul A; Logan, Brent R; Lee, Stephanie J et al. (2018) A phase II/III randomized, multicenter trial of prednisone/sirolimus versus prednisone/ sirolimus/calcineurin inhibitor for the treatment of chronic graft-versus-host disease: BMT CTN 0801. Haematologica 103:1915-1924
Holstein, Sarah A; Avet-Loiseau, Hervé; Hahn, Theresa et al. (2018) BMT CTN Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling: Summary and Recommendations from the Organizing Committee. Biol Blood Marrow Transplant 24:641-648
Jacobsohn, David A; Loken, Michael R; Fei, Mingwei et al. (2018) Outcomes of Measurable Residual Disease in Pediatric Acute Myeloid Leukemia before and after Hematopoietic Stem Cell Transplant: Validation of Difference from Normal Flow Cytometry with Chimerism Studies and Wilms Tumor 1 Gene Expression. Biol Blood Marrow Transplant 24:2040-2046
Smith, Eileen P; Li, Hongli; Friedberg, Jonathan W et al. (2018) Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703). Biol Blood Marrow Transplant 24:700-707
Nemecek, Eneida R; Hilger, Ralf A; Adams, Alexia et al. (2018) Treosulfan, Fludarabine, and Low-Dose Total Body Irradiation for Children and Young Adults with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Hematopoietic Cell Transplantation: Prospective Phase II Trial of the Pediatric Blood Biol Blood Marrow Transplant 24:1651-1656
Rashidi, Armin; Wangjam, Tamna; Bhatt, Ami S et al. (2018) Antibiotic practice patterns in hematopoietic cell transplantation: A survey of blood and marrow transplant clinical trials network centers. Am J Hematol 93:E348-E350
Robinson, Tara M; Fuchs, Ephraim J; Zhang, Mei-Jie et al. (2018) Related donor transplants: has posttransplantation cyclophosphamide nullified the detrimental effect of HLA mismatch? Blood Adv 2:1180-1186
Gadalla, Shahinaz M; Aubert, Geraldine; Wang, Tao et al. (2018) Donor telomere length and causes of death after unrelated hematopoietic cell transplantation in patients with marrow failure. Blood 131:2393-2398
Duncan, Christine N; Brazauskas, Ruta; Huang, Jiaxing et al. (2018) Late cardiovascular morbidity and mortality following pediatric allogeneic hematopoietic cell transplantation. Bone Marrow Transplant 53:1278-1287
Andermann, Tessa M; Peled, Jonathan U; Ho, Christine et al. (2018) The Microbiome and Hematopoietic Cell Transplantation: Past, Present, and Future. Biol Blood Marrow Transplant 24:1322-1340

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