Collection of Samples and Data for the National Marrow Donor Program Repository

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00495300
First received: June 30, 2007
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the Research Database Program and the Research Sample Repository.

Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study.

Participants in the NMDP Research Database program will have medical information about their disease and their transplant sent to the NMDP before and after the transplant and once a year for the rest of their life. The information will be used to help determine how well transplant recipients recover from their transplant, how recovery after a transplant can be improved, how access to transplant for different groups of patients can be improved and how well donors recover from collection procedures.

Participants in the NMDP Research Sample Repository program will have a small blood sample drawn from a vein in the arm just before they start taking medicines for the conditioning regimen to prepare them for the transplant. The blood samples will be used to look at ways to improve how patients are matched with their donors, to determine and evaluate the factors that affect transplant outcome, and to help develop methods to improve tissue matching between donors and recipients.


Condition
Hematopoietic Stem Cell Transplantation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Collection of Research Samples and/or Data for Repository From Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary objective for this study is to meet data submission requirements as set forth by the NMDP.

Secondary Outcome Measures:
  • The secondary objective for this study is to enroll all patients receiving an NMDP facilitated transplant at the NIH onto one unifying protocol.

Estimated Enrollment: 500
Study Start Date: June 2007
Detailed Description:

The National Institutes of Health (NIH) has entered into a Transplant Center Participation Agreement with the National Marrow Donor Program (NMDP). This agreement allows any NIH investigator with an NIH Institutional Review Board (IRB) approved protocol to secure hematopoietic stem cells (HSC) or cord blood units from the NMDP/CIBMTR registry for the purpose of transplanting patients who have no suitable matched related donors. As part of this agreement, the NMDP/CIBMTR Research Program requires that blood samples as well as baseline and outcome data (mainly demographic, quality of life, and clinical data) be collected and maintained in accordance with the NMDP/CIBMTR IRB approved protocols. The goal of the NMDP/CIBMTR Research Program is to improve the safety and effectiveness of unrelated donor HSC transplantation for both the donors and recipients, and to have a comprehensive source of data that can be used to study unrelated donor HSC transplantation. The NMDP/CIBMTR is the sole custodian of the data in the Research Database.

The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) level data submission for NIAID Allogeneic recipient patients and their donors. This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive matched unrelated donor (MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also include patients that have undergone a MUD transplant at another approved transplant center but need to receive additional blood products from the donor while at NIH after completing a transplant center transfer.

  Eligibility

Ages Eligible for Study:   1 Year to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients (Recipient):

Must be enrolled on an NIH IRB approved protocol which involves an HSC transplant or cellular therapy utilizing HSC from an unrelated donor affiliated with the NMDP.

May include recipients who have received an NMDP facilitated HSC transplant at other institutions, provided the patient consents to and completes a Transplant Center transfer.

Ability to comprehend and willing to sign the informed consent or have a parent/guardian consent if the donor is a minor; assent obtained from minors as appropriate.

NIAID Allogeneic (related matched) recipients for TED level data submission only.

Donors of related transplant.

EXCLUSION CRITERIA:

The patient has received an HSC transplant or cellular therapy utilizing HSC from an unrelated donor facilitated by a registry other than NMDP.

Non-NIAID Allogeneic (sibling matched) Recipients.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495300

Contacts
Contact: Dianne M Hilligoss, C.R.N.A. (301) 594-5945 dhilligoss@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Dianne M Hilligoss, C.R.N.A. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00495300     History of Changes
Other Study ID Numbers: 070183, 07-I-0183
Study First Received: June 30, 2007
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HSC/MUD Transplant
NMDP
NMDP Data Collection
NMDP Samples
BMT
Samples

ClinicalTrials.gov processed this record on July 22, 2014