T-Cell Depleted Double UCB With Post Transplant IL-2 for Refractory Myeloid Leukemia
This single center study will determine the feasibility and safety of using a myeloablative
conditioning regimen followed (on day 0) by transplantation with double T-cell depleted
(TCD) umbilical cord blood (UCB) units where the unit with fewer mononuclear cells (MNCs)/kg
will be selected for overnight IL-2 activation prior to infusion. Beginning on day +3, post
transplant IL-2 will be administered thrice weekly, not on consecutive days, for a total of
6 doses to expand UCB derived progenitor cells. Post transplant immune suppression
prophylaxis will not be administered with the intent to lessen toxicity and allow allogeneic
NK cells to function longer providing better anti-leukemic therapy. However if either UCB
unit has more than 5% T-cells, the patient will not receive either course of IL-2. Beginning
on day +60 after transplantation, a second course of IL-2 will be administered thrice
weekly, not on consecutive days, for a total of 6 doses with the purpose of enhancing the in
vivo expansion and education of NK cells derived from engrafting UCB cells.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Free Survival
The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo.
At 3 months
Michael Verneris, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|