NCT00935597

Host Dendritic Cells in Allograft Patients

A Phase I Trial of Host Dendritic Cell Infusion After Allogeneic Stem Cell Transplant for Prevention or for Treatment of Relapsed Disease in Patients With Advanced Hematologic Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.

Conditions

• Relapsed Non-Hodgkin's Lymphoma
• Hodgkin's Disease
• Multiple Myeloma
• Chronic Lymphocytic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)	Patients who have minimal residual disease or minimal volume relapse, and are at least four weeks post immunosuppression following allogeneic stem cell transplantation will receive a series of four HDC infusions (100,000 HDC/kg per infusion, one every four weeks(group 1). Those patients who have greater than minimal residual disease will receive HDC infusions, one every four weeks in conjunction with donor lymphocyte infusion (DLI) (group 2).

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-07-01
• First posted: 2009-07-09
• Last updated: 2010-10-29

Locations

1 site across 1 country: United States