Long-Term Follow-up of People Undergoing Hematopoietic Stem Cell Transplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 4 - 99 |
| Updated: | 3/10/2019 |
| Start Date: | April 26, 2017 |
| End Date: | August 12, 2021 |
| Contact: | Jennifer L Sadler |
| Email: | jennifer.sadler@nih.gov |
| Phone: | (240) 760-6172 |
Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
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.
Background:
- 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.
Objective:
-To collect clinical data on patients and late complications after HCT
Eligibility:
- 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.
Design:
- 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.
- 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.
Objective:
-To collect clinical data on patients and late complications after HCT
Eligibility:
- 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.
Design:
- 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.
- 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 greater than or equal to 1 year) OR patients who will be
undergoing HCT for any indication (malignant or non-malignant) on an ETIB protocol.
Patients do not need to have been transplanted under an ETIB protocol.
- Age greater than or equal to 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 care physician 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 greater than or equal to 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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