Protocol Details
Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation, Cellular Therapy, or Gene Therapy
This study is currently recruiting participants.
Summary
Number |
17-C-0027 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 Years
Max Age: 120 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Keywords |
Cellular Therapy;
Gene Therapy;
Natural History;
HCT |
Recruitment Keyword(s) |
None |
Condition(s) |
Cellular Immunotherapy, Adoptive;
Genetic Therapy;
Tissue Donors;
Hematopoietic Stem Cell Transplantation |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
Background:
People who have had an allogeneic hematopoietic stem cell transplant (HCT), cellular therapy (CT), or gene therapy (GT) 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, CT, or GT. 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, CT, or GT. To collect data, blood, and tissue samples to learn about late complications after HCT, CT, or GT.
Eligibility:
Adults age 18 and older who will undergo HCT or underwent HCT, Cellular Therapy (CT), or Gene Therapy (GT) and are surviving one year or more from the date of therapy. 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.
Eligibility
INCLUSION CRITERIA FOR PATIENT SUBJECTS:
-Individuals who underwent HCT or received cellular or gene therapy for any indication (malignant or non-malignant) and are surviving one year or more from the date of therapy
-Age >= 4 years
-Ability of individual or individual s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
-Individuals will need to have a primary physician within the US (primary care, oncologist, hematologist, etc.) that will provide continued comprehensive care for the duration of participation in the study. PI may allow for established medical providers to be located outside of the US.
EXCLUSION CRITERIA FOR PATIENT SUBJECTS:
-Individuals 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 hematopoietic progenitor and stem cells or leukocytes
-Age >= 4years
-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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03000244