Long-Term Follow-up of People Undergoing Hematopoietic Stem Cell Transplantation

NCT03000244 | Recruiting

• 2 other identifiers: 17002717-C-0027
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: People who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow or an immune system that is damaged. They get stem cells from a donor who is a relative. Researchers want to study stem cell donors and recipients to learn about the long-term effects of HCT. They want to learn how the stem cells change and how to improve their ability to fight cancer. Objective: To provide long-term follow-up care for people who underwent or will undergo HCT. To collect data, blood, and tissue samples to learn about late complications after HCT. Eligibility: Adults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or more from the date of HCT. The stem cell donors for these recipients are also needed. Design: Recipients will have 1 visit each year. They will have a physical exam. They will answer questions about their medical history and health. They will receive screening and surveillance testing. They will complete brief questionnaires. Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue in their cheek or skin or bone marrow biopsy). Recipients will give their current address and phone number, and the same data for one or two other people, who can get in contact with them. After the first visit at the clinic, some recipients may see a doctor close to home to get the necessary information and send it to NIH. Donors will come to the clinic for 1 visit. They will answer questions about their medical history. Blood samples will be taken.

Conditions

Hematopoietic Stem Cell Transplantation; Tissue Donors

Keywords

Natural History; HCT

Outcome Measures

Primary Outcomes (1)

• Basic characteristics of the patient population

  Survival

  at death

Secondary Outcomes (4)

• Provide a mechanism to ensure implementation of standard of care recommendations for post-transplant followup

  Ongoing throughout study

• Obtain blood samples from stem cell transplant donors to study how biological factors related to the donor are associated with late complications

  Ongoing throughout study

• Obtain blood and tissue samples to study and document immunologic reconstitution after stem cell transplant

  Ongoing throughout study

• Monitoring of late effects after stem cell transplant for patients of ETIB protocols

  Ongoing throughout study

Study Arms (3)

1/Patients

Patients who underwent hematopoietic stem cell transplant for any indication (malignant or non-malignant).

2/Donors

Related stem cell donors of those in Patients cohort.

3/Parents of patients

Parents/guardians of minors enrolled in cohort 1

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received an allogeneic stem cell transplant as well as donors of stem cells who are related to the patients who are study participants. Parents of minor recipients may also be enrolled to complete surveys. Participants can be from any community or co-enrolled on another NIH protocol.

You may qualify if:

• Patients who underwent HCT for any indication (malignant or non-malignant) and are surviving one year or more from the date of HCT (patients may be at any time point after HCT as long as it is \>=1 year).
• Age \>= 4 years
• Ability of patient or patient's Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
• Patients will need to have a primary physician within the US (primary care, oncologist, hematologist, etc.) that will provide continued comprehensive care throughout the patient's participation in the study

You may not qualify if:

• Patients with active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.
• Related stem cell donors of patients meeting the above criteria as a donor of stem cells or leukocytes
• Age \>= 4 years
• Ability of patient or patient's Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed
• consent document
• Parents/guardians of minors enrolled on the study who have undergone HCT
• Willingness to complete surveys about the minor that underwent HCT

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Najla El Jurdi, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley E Carpenter

CONTACT

(240) 550-0492; carpentera@mail.nih.gov

Najla El Jurdi, M.D.

CONTACT

(240) 992-4033; najla.eljurdi@nih.gov

Study Design

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

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 22, 2016
• Study Start: April 26, 2017
• Primary Completion (Estimated): August 12, 2050
• Study Completion (Estimated): August 12, 2050
• Last Updated: June 5, 2026

Record last verified: 2026-05-26

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Data from this study may be requested by contacting the PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)