Key Dates

Related Announcements

• June 21, 2023 - The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional). See NOFO RFA-HL-24-010.
• June 21, 2023 - The Blood and Marrow Transplant Clinical Trials Network - Data Coordinating Center (U24 Clinical Trial Not Allowed). See NOFO RFA-HL-24-011. 

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to alert potential applicants to changes in Part I and Part 2 Sections I and IV for RFA-HL-24-010 "The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional)". This Notice of Funding Opportunity (NOFO) was issued on 6/21/2023. Changes to the NOFO are shown in bold italics below.

Part 1. Funding Opportunity Purpose

Currently Reads:

This is an open competition for new applications and/or the renewal of an existing program.

Modified to Read (in bold italics):

This is an open competition for new applications and/or the renewal of a Core Clinical Center or Consortium in the current program.

Section I. Notice of Funding Opportunity Description

Currently Reads:

CCCs should have the infrastructure to evaluate ex vivo manipulated and genetically modified cells and have a catchment area or collaborations in place to enroll participants from minority health and health disparity populations, which include patient populations diverse in age, ethnicity, gender, and geographic area.

Modified to Read (in bold italics):

CCCs should have the infrastructure to evaluate ex vivo manipulated and genetically modified cells and have a catchment area or collaborations in place to enroll participants inclusive of minority health and health disparity populations, as well as representation across age ranges, ethnicities, genders, and regional geographic areas.

Section I. Notice of Funding Opportunity Description

Currently Reads:

1. Provide scientific leadership and expertise to work cooperatively to develop and efficiently conduct multi-site HCT trials for children and adults with non-malignant and malignant blood diseases, as well as trials that incorporate adoptive cell therapies such as ex vivo expanded and genetically modified cells.

Modified to Read (in bold italics):

1. Provide scientific leadership and expertise to work cooperatively to develop and efficiently conduct multi-site HCT trials for children and adults with non-malignant and malignant blood diseases, as well as trials that incorporate adoptive cell therapies such as ex vivo expanded and genetically modified cells for these indications.

 Section IV. Application and Submission Information, SF424(R&R) Cover

Currently Reads:

Title of the Applicant’s Project: Applicants must use the naming convention “BMT Core - [insert name of Site or Consortium]"

Modified to Read (in bold italics): 

Title of the Applicant’s Project: Applicants must use the naming convention “BMT CTN Core - [insert name of Site or Consortium]"

Section IV. Application and Submission Information, SF424(R&R) Other Project Information, 2. Transplant Activity (Transplant Activity) – Required

Currently Reads:

3) Racial Categories, below
  a. Non-White
  b. White
  c. Multiracial, Unknown or Not Reported4) Graft/Donor Source
a. Autologous
b. HLA-identical siblings
c. Haplo-identical donors (and mismatched related)
d. Unrelated donors

Modified to Read (in bold italics): 

3) Racial and Ethnic Categories, below
 a. American Indian/Alaska Native
 b. Asian
 c. Native Hawaiian or Other Pacific Islander
 d. Black or African American
 e. White
 f.  More than one Race
 g. Race Unknown or Not Reported
h. Hispanic or Latino Ethnicity
i.  Non-Hispanic or Latino Ethnicity
k. Unknown or Not Reported Ethnicity

Section IV. Application and Submission Information, PHS 398 Research Plan

Currently Reads:

Describe challenges, successes and lessons learned from up to three HCT trials/studies in each of the 4 categories in the bullets below:

• Trials that struggled with recruitment or retention of subjects, and how challenges were addressed.
• Trials that engaged a team having a diverse background or expertise, the degree to which this impacted the trial.
• Early phase HCT trials from the prior 6 years that led to a multi-site trial.
• FDA-regulated clinical trials for recipients of HCT or adoptive cell therapy.

Modified to Read (in bold italics):

Describe challenges, successes and lessons learned from up to three HCT trials/studies, for example:

• Trials that struggled with recruitment or retention of subjects, and how challenges were addressed.
• Trials that engaged a team having a diverse background or expertise, the degree to which this impacted the trial.
• Early phase HCT trials from the prior 6 years that led to a multi-site trial.
• FDA-regulated clinical trials for recipients of HCT or adoptive cell therapy.

 All other aspects of this NOFO remain unchanged.

Inquiries

Please direct all inquiries regarding this Notice to:

Nancy L. DiFronzo, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0065
Email: nancy.difronzo@nih.gov

Lori A. Henderson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5930
Email: hendersonlori@mail.nih.gov