Long-Term Follow-up of People Undergoing Hematopoietic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT03000244|
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : November 12, 2018
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.
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.
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.
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.
|Condition or disease|
|Hematopoietic Stem Cell Transplantation Tissue Donors|
- Patients who survive more than 3 years after allogeneic hematopoietic stem cell transplantation (HCT) have a high probability of being cured from their underlying disease; however, mortality rates remain 4 to 9-fold higher than the general population for at least 30 years after HCT.
- The most common causes of late mortality in HCT survivors include second malignancies, relapsed/recurrent disease, infections, chronic graft-versus-host disease (GVHD), respiratory diseases, and cardiovascular diseases.
- Guidelines for recommended screening and preventive practices for long-term survivors after HCT have been developed, and can be implemented to detect or prevent late complications after HCT.
- Understanding the pattern of immune reconstitution and immune dysregulation after HCT may help to elucidate the root mechanisms of late complications.
-To collect clinical data on patients and late complications after HCT
- Patients who underwent HCT for any indication and are surviving one year or more from the date of HCT OR patients who will be undergoing HCT on an ETIB protocol.
- Related stem cell donors of patients meeting the above criteria who participated or will be participating as a donor of stem cells or leukocytes.
- Age greater than or equal to 4 years
- Any active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.
- Prospective, longitudinal study of the natural history of long-term survivors after HCT.
- Clinical data on post-transplant complications and peripheral blood samples will be collected at yearly evaluations by the Principal Investigator, LAI, AI or representative investigator of the original HCT protocol.
- If patient develops complications such as new cancers, relapsed disease, new hematologic malignancy or PTLD they can be exempt from required evaluations, and followed for survival and causes of death (management of complications as per primary team).
- As this is a longitudinal registry study without any planned intervention, there is no formal statistical analysis plan or accrual goal; descriptive data will be reported.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation|
|Actual Study Start Date :||April 26, 2017|
|Estimated Primary Completion Date :||August 12, 2021|
|Estimated Study Completion Date :||August 12, 2021|
Patients who underwent hematopoietic stem cell transplant for any indication (malignant ornon-malignant).
Related stem cell donors of those in Patients cohort.
3/Parents of patients
Parents/guardians of minors enrolled in cohort 1
- Basic characteristics of the patient population. [ Time Frame: At death. ]Survival
- Monitoring of late effects after stem cell transplant for patients of ETIB protocols [ Time Frame: Ongoing throughout study ]Survival and observation of long-term outcomes.
- Provide a mechanism to ensure implementation of standard of carerecommendations for post-transplant followup [ Time Frame: Ongoing throughout study ]Observation of adherence and effects of standard of carerecommendations
- Obtain blood and tissue samples to study and document immunologicreconstitution after stem cell transplant [ Time Frame: Ongoing throughout study ]Immune monitoring for analysis
- Obtain blood samples from stem cell transplant donors to study howbiological factors related to the donor are associated with latecomplications [ Time Frame: Ongoing throughout study ]Studying donor samples for potential correlations to transplantrecipient complications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000244
|Contact: Jennifer L Sadler||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Steven Z Pavletic, M.D.||National Cancer Institute (NCI)|