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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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 |
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| Group 2 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading. | 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism | 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion |
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Inclusion Criteria:
Age 18-70
Ability to sign informed consent
ECOG performance status ≤3
Life expectancy > 6 months
Adequate cardiac function: MUGA or Echocardiogram demonstrating >50% Ejection Fraction
Adequate pulmonary function with DLCO > 50%
Adequate hepatic function
Adequate renal function Estimated creatinine clearance > 40ml/min
Diagnosis of one of the following
Eligible for allogeneic stem cell transplant with identified HLA-identical sibling (6/6 HLA match) or volunteer unrelated donor (8/8 allele HLA-matched (A, B, Cw, DRB1)
Women of childbearing potential must have a negative serum pregnancy test prior to enrollment
Women of childbearing potential must use effective means of birth control throughout the study.
Men should not father a child while enrolled in the study. Effective means of birth control include condom, vasectomy or abstinence.
Exclusion Criteria:
Patient Exclusion Criteria for Part B (post Stem Cell Transplant)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keren Osman, MD | Contact | (212)241-6021 | keren.osman@mssm.edu | |
| Linda Sacris, RN | Contact | (212)824-7339 | linda.sacris@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keren Osman, M.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Recruiting | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D009101 | Multiple Myeloma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D016393 | Lymphoma, B-Cell |