RFA-HL-17-019: Limited Competition: Data Coordinating Center for the Blood and Marrow Transplant Clinical Trials Network (U24)
LOI: October 10, 2016, 5pm PDT
Internal Deadline: September 16, 2016, 5pm
External Deadline: November 10, 2016, 5pm
Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Amount: NHLBI intends to commit total costs of up to $1,745,200 in FY 2017
Cost Sharing: This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt.).
- CV – (5 pages maximum)
Who May Serve as PI: Standard NIH requirements.
The DCC will work with the NHLBI, the NCI, and the Core Clinical Center awardees to improve patient outcomes following HCT through clinical trials and other clinical studies for patients with malignant and non-malignant blood diseases. In this funding cycle and as compared to the previous phases of the program, Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is expected to direct more efforts towards the use of HCT and novel cell/gene therapies and refining HCT approaches for non-malignant blood disorders. In particular, clinical studies that advance HCT approaches for non-malignant blood diseases and bone marrow failure syndromes where toxicity must be minimized will be considered key priorities. Trials evaluating ex vivo manipulated or genetically-modified cells in non-malignant and malignant blood diseases will be encouraged. Trials evaluating new approaches for stem cell mobilization, or that incorporate novel cell products to improve HCT safety and efficacy, reduce regimen-related toxicity and GVHD, and/or enhance immune function, will also be considered for implementation.
This FOA will support a DCC, while a companion FOA will support up to 18 Core Clinical Centers that may be single sites or a consortium of multiple sites (RFA-HL-17-018). It is anticipated that up to eight BMT CTN-led studies will be conducted depending on their complexities. This FOA seeks a comprehensive plan from the current DCC of the BMT CTN that addresses the overall project coordination, administration, data management, statistical support, and regulatory support that are necessary to successfully support the next phase of the BMT CTN with attention to the following goals:
1) Provide medical and scientific leadership to enhance the overall effectiveness of the BMT CTN.
2) Provide a plan for the BMT CTN to identify and, when appropriate, launch HCT trials in non-malignant diseases and trials using adoptive cell therapy or genetically-modified cells to improve transplant outcomes or cure blood diseases.
3) Provide overall management of scientific activities around study development, trial launch, data analysis and results dissemination, including completing ongoing trials.
4) Provide all administrative activities for the BMT CTN.
5) Provide all logistical and other support services for the BMT CTN.
Visit our Institutionally Limited Submission webpage for updates and other announcements.