An observational study in Graft-versus-leukemia, Graft vs Host Disease and Graft Rejection, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 7 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational
This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.
Patients between 10 and 80 years of age who received a donor stem cell transplant at the NIH Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
Participants are generally seen in the clinic every 12 months for some or all of the following procedures:
Imaging tests to visualize organs, tissues, and cellular activity in specific tissues. For these tests, the patient lies on a table that slides into the scanner. They may include the following:
Heart function tests may include the following:
Disease relapse or progression, or transplant-related problems may be treated with standard medical, radiation, or surgical therapy, or patients may be offered experimental therapy.
While patients surviving more than three years from SCT have a high probability of being cured of their underlying disease, they are still at risk from several categories of complications which could remain lifelong risks including late recurrence (or continued persistence) of original disease, late effects from transplant related GVHD, immune dysfunction, or consequences from the chemotherapy and/or radiation given during transplant conditioning.
Since these complications are iatrogenic, the long term follow-up of SCT patients is the ethical responsibility of the transplant team. In addition, collecting data on late occurring complications allows for prospective evaluation of the long term consequences of surviving a particular transplant treatment approach (i.e. total body irradiation versus chemotherapy conditioning, T cell depleted versus T cell replete transplants).
This protocol is designed to allow for long term evaluation, data collection, and when needed, standard medical care of patients (and when appropriate their stem cell donor) who have received allogeneic stem cell transplantation in NHLBI protocols. This may include patients with bone marrow failure states, cytopenias, hemoglobinopathies, metastatic solid tumors, or hematologic malignancies.
No investigational treatments will be administered on this protocol. Participation will not constitute a promise of long-term medical care at the NIH, nor will it provide for the evaluation and treatment of any non-transplant related medical problems. This protocol will provide access to NIH hematologists experienced in the care of post transplant patients who can help transplant patients and their local physician manage post transplant complications. In return, data collected from subjects and their donors (when applicable) will provide NIH researchers valuable information and/or laboratory samples for the purposes of better understanding the long term consequences of stem cell transplantation and identifying areas in need of future research.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 94 across 102 observational studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients and donors (when applicable) will be co accrued to this protocol once they have survived a minimum of three years from date of transplant.
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
allogeneic stem cell transplant recipients
Donors
Assure consistency of care over time for transplant patients such that outcome data can be meaningfully accrued.
monitor late effects of treatment and provide or recommend appropriate management
Time frame: Ongoing
Monitor the late effects of treatment and provide or recommend appropriate management
To collect long-term follow-up data and laboratory research samples on SCT recipients to determine outcomes for particular transplant treatment approaches.
Time frame: ongoing
Describe natural history of the primary disease process. Provide fellowship training in Hematology and Oncology.
Patients will be evaluated at 4, 5 and 7 years post-transplant, then every 5 years after that to monitor the natural history of their disease, to evaluate the long term effects of transplantation, and to provide for or recommend appropriate clinical management
Time frame: ongoing
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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National Heart, Lung, and Blood Institute (NHLBI)