Long-term follow-up care for patients who received stem cell transplants
Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants
National Institutes of Health Clinical Center (CC) · NCT00106925
This study looks at how people aged 10 to 80 who received stem cell transplants are doing over time to see how well they respond to treatment and if they have any long-term issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 7 Years to 80 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00106925 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the long-term evaluation and follow-up care of patients who have undergone allogeneic stem cell transplantation at the NIH Clinical Center. Participants, aged between 10 and 80 years, are monitored for their response to treatment, disease relapse, and late-occurring effects of the transplant. The study includes periodic physical examinations, blood tests, and bone marrow biopsies to assess complications such as graft-versus-leukemia and graft-versus-host disease. The aim is to collect data on long-term outcomes and complications associated with different transplant approaches.
Who should consider this trial
Good fit: Ideal candidates are patients aged 10 to 80 who received a donor stem cell transplant at the NIH Clinical Center at least three years prior.
Not a fit: Patients who have not undergone a stem cell transplant or those who had their transplant outside the NIH without a special condition of interest may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve long-term care and management strategies for patients who have undergone stem cell transplants.
How similar studies have performed: While long-term follow-up studies for stem cell transplant patients are common, this specific observational approach is designed to systematically evaluate late complications and is a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA-TRANSPLANT RECIPIENTS: Patients surviving three years or more from date of first stem cell transplant who have been treated. -With an experimental allogeneic stem cell transplant on a NHLBI HB protocol Or -With a standard of care allogeneic stem cell transplant on an NHLBI protocol Or -Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team Age greater than or equal to 7 years old and age less than or equal to 80 For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend. EXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS: None, all patients meeting the inclusion criteria will be eligible
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Richard W Childs, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Bretagne C Cowling, R.N.
- Email: bretagne.cowling@nih.gov
- Phone: (301) 827-3479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Graft-versus-leukemia, Graft vs Host Disease, Graft Rejection, Peripheral Blood Stem Cells, Graft Versus Leukemia/Myeloma, Graft Versus Host Disease, Whole Body Irradiation, Leukemic Relapse