Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.|
- Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion. [ Time Frame: Up to 21 days post transplant ]After drug infusion, participants will be closely monitored for at least 4 hours for side effects
- To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level. [ Time Frame: days 0 and 21 post autologous stem cell transplantation ]
- To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose. [ Time Frame: days 0 and 21 post autologous stem cell transplantation ]
- To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose. [ Time Frame: days 0 and 21 post autologous stem cell transplantation ]During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.
|Study Start Date:||November 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Denileukin Diftitox (Ontak)
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
Drug: Denileukin Diftitox (Ontak)
After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.
Other Name: Ontak®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251952
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Principal Investigator:||Zaid Al-Kadhimi, M.D.||Barbara Ann Karmanos Cancer Institute|