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

NCT00495300 | Completed

• 2 other identifiers: 07018307-I-0183
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Marrow Transplantation

Keywords

Data Collection; CIBMTR Samples; NMDP Repository; Hematopoietic Stem Cells; Bone Marrow Transplant Data Collection; Natural History; Samples

Outcome Measures

Primary Outcomes (1)

• 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) leve...

  Ongoing

  Ongoing

Study Arms (1)

1

Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive related donor transplants as well as 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

You may qualify if:

• 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.
• Allogeneic (related matched) recipients for TED level data submission only.
• Donors of related transplant.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Dufour C, Rondelli R, Locatelli F, Miano M, Di Girolamo G, Bacigalupo A, Messina C, Porta F, Balduzzi A, Iorio AP, Buket E, Madon E, Pession A, Dini G, Di Bartolomeo P; Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP); Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Stem cell transplantation from HLA-matched related donor for Fanconi's anaemia: a retrospective review of the multicentric Italian experience on behalf of AIEOP-GITMO. Br J Haematol. 2001 Mar;112(3):796-805. doi: 10.1046/j.1365-2141.2001.02572.x.

  PMID: 11260086 BACKGROUND

• Chakraverty R, Peggs K, Chopra R, Milligan DW, Kottaridis PD, Verfuerth S, Geary J, Thuraisundaram D, Branson K, Chakrabarti S, Mahendra P, Craddock C, Parker A, Hunter A, Hale G, Waldmann H, Williams CD, Yong K, Linch DC, Goldstone AH, Mackinnon S. Limiting transplantation-related mortality following unrelated donor stem cell transplantation by using a nonmyeloablative conditioning regimen. Blood. 2002 Feb 1;99(3):1071-8. doi: 10.1182/blood.v99.3.1071.

  PMID: 11807015 BACKGROUND

• Kolb HJ, Socie G, Duell T, Van Lint MT, Tichelli A, Apperley JF, Nekolla E, Ljungman P, Jacobsen N, van Weel M, Wick R, Weiss M, Prentice HG. Malignant neoplasms in long-term survivors of bone marrow transplantation. Late Effects Working Party of the European Cooperative Group for Blood and Marrow Transplantation and the European Late Effect Project Group. Ann Intern Med. 1999 Nov 16;131(10):738-44. doi: 10.7326/0003-4819-131-10-199911160-00004.

  PMID: 10577296 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

• Harry L Malech, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2007
• First Posted: July 3, 2007
• Study Start: August 31, 2007
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

US (1)