NCT01251952

Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation

Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2013-05-01
• First posted: 2010-12-02
• Last updated: 2017-06-20
• Results posted: 2013-12-16

Locations

1 site across 1 country: United States