Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
The primary goal of this study is to determine the feasibility and safety of giving two doses
of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a
dose escalation fashion. Secondary goals include evaluating the the effect of DD on the
number and percentage of T-regs in the peripheral blood post transplant at each dose level,
the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and
determining the time to engraftment: absolute neutrophil count (>0.5 x 10^9/L for 3
consecutive days), and platelet (>20X 10^9/L for 3 consecutive days).
The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently
enhance the immune reconstitution and reverse post transplant lymphopenia. This may
indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.