Notice of Intent to Publish a Funding Opportunity Announcement for Core Clinical Centers for the Bone and Marrow Transplant Clinical Trials Network (U10)

Notice Number: NOT-HL-16-315

Key Dates
Release Date:  April 5, 2016
Estimated Publication Date of Announcement: Summer 2016  
First Estimated Application Due Date: Fall 2016  
Earliest Estimated Award Date: July 2017  
Earliest Estimated Start Date: September 2017

Related Announcements
RFA-HL-17-018

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The National Heart, Lung, and Blood Institute intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for the Core Clinical Centers of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).  The goals of the BMT CTN are to advance hematopoietic cell transplantation (HCT) for all patients, but particularly for patients with rare and difficult to treat blood diseases.  This will be accomplished by advancing traditional HCT approaches and by using novel cell and gene therapy approaches.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in July 2016, with an application due date in September 2016.

This FOA will utilize the U10 cooperative agreement mechanism.

Research Initiative Details

The planned renewal of the BMT CTN will be solicited through two FOAs. The FOA announced by this Notice is for the Core Clinical Centers, while the FOA announced in NOT-HL-16-314 is for the Data and Coordinating Center (DCC). 

It is anticipated that the FOA for Core Clinical Centers will seek up to 18 Core Clinical Centers with investigator teams experienced in HCT, novel cell therapies, and both malignant and non-malignant blood diseases. Applications may include a single HCT center or a consortium of HCT centers, and propose one clinical trial concept to evaluate novel HCT approaches or evaluate a proven HCT approach in a new patient population. Concepts for early phase trials for patients with non-malignant blood diseases are encouraged, as are concepts for trials using novel cell and gene therapy approaches.

Core Clinical Centers will be expected to commit to actively enroll participants in BMT CTN trials.  Successful applicants should be able to demonstrate their ability to identify, enroll and retain participants in multi-center HCT studies, and have the expertise and resources needed to support the activities of a clinical trials network simultaneously conducting 6-8 studies focused on improving HCT outcomes for all patients including those with non-malignant blood diseases. Additional experience in public-private partnerships, conducting studies under the purview of the Food and Drug Administration, and multidisciplinary research will be beneficial.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Nancy DiFronzo, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0080
Email: difronzon@nhlbi.nih.gov