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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 21, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term effects of hematopoietic stem cell transplantation (HCT), a treatment used for people with damaged bone marrow or immune systems. The study focuses on both the recipients of the stem cells, who receive them from a relative, and the donors. Researchers want to learn how these stem cells change over time and how they can be improved to better fight cancer.

Adults aged 18 and older who have had an HCT and are at least one year post-transplant, as well as those who will soon undergo the procedure, are eligible to participate. Participants will visit the clinic once a year for a physical exam, answer questions about their health, and may undergo blood tests or tissue samples. Stem cell donors will also have a single visit for questions and blood sampling. This study aims to provide ongoing care and gather important information about late complications following the transplant, helping to improve future treatments.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA FOR PATIENT SUBJECTS:
• • 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
• EXCLUSION CRITERIA FOR PATIENT SUBJECTS:
• • -Patients with active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.
• INCLUSION CRITERIA FOR DONOR SUBJECTS:
• • 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
• INCLUSION CRITERIA FOR PARENTS COMPLETING SURVEYS:
• • Parents/guardians of minors enrolled on the study who have undergone HCT
• • Willingness to complete surveys about the minor that underwent HCT