A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies
This research protocol has been developed for patients undergoing matched-sibling
hematopoietic stem cell transplant (HSCT). The patients who are treated according to this 2
step allogeneic HSCT protocol will receive cyclophosphamide to induce in-vivo tolerization
of both autologous and allogeneic lymphocytes, followed by an allogeneic CD34-selected HSCT.
The primary research questions relate to immune reconstitution, incidence of GVHD, and
relapse in patients who receive lymphocyte treatment of this type in allogeneic HSCT and how
it impacts overall survival.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Neal Flomenberg, MD
Thomas Jefferson University
United States: Food and Drug Administration
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