Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants
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.
Observational
N/A
Minocher M Battiwalla, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
United States: Federal Government
050130
NCT00106925
March 2005
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |