Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
|ClinicalTrials.gov Identifier: NCT01251952|
Recruitment Status : Terminated (Drug unavailable)
First Posted : December 2, 2010
Results First Posted : December 16, 2013
Last Update Posted : June 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Denileukin Diftitox (Ontak)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||May 2013|
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®
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|