A Phase 1 interventional study of MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) in Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease and Multiple Myeloma, sponsored by Icahn School of Medicine at Mount Sinai. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-29.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 1, Interventional, and Treatment
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.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 25 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 763 studies on the registry; 180 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Adequate hepatic function
Diagnosis of one of the following
Exclusion Criteria:
Patient Exclusion Criteria for Part B (post Stem Cell Transplant)
Patients with Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion
Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
Patients with greater than Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion in conjunction with donor lymphocyte infusion (DLI)
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).
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
Time frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism
Time frame: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai