Host Dendritic Cells in Allograft Patients
Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed Non-Hodgkin's Lymphoma focused on measuring Relapsed Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Chronic Lymphocytic Lymphoma, Relapsed Non-Hodgkin's lymphoma (excluding follicular lymphoma and marginal zone lymphoma)
Eligibility Criteria
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
- Bilirubin ≤ 1.5mg/dl
- Alkaline phosphatase ≤5 times the upper limit of normal
- Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transferase (SGOT) ≤ 3 times the upper limit of normal
- Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≤ 3 times the upper limit of normal
- Adequate renal function Estimated creatinine clearance > 40ml/min
Diagnosis of one of the following
- Non-Hodgkin's lymphoma excluding Follicular lymphoma and Marginal Zone Lymphoma
- Hodgkin's lymphoma
- Multiple myeloma
- Chronic lymphocytic leukemia
- 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:
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
- Prior allogeneic stem cell transplant
- History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- Active infections including fungal infections and viral hepatitis
- GVHD greater than grade I GVHD of the skin
Patient Exclusion Criteria for Part B (post Stem Cell Transplant)
- Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- Concurrent illnesses that would preclude survival > 6 months other than the disease under study.
- Pregnancy or nursing
- HIV infection
- Treatment with prior donor lymphocyte infusion
- Prior allogeneic stem cell transplant
- More than 4 prior relapses
- History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- Active infections including fungal infections and viral hepatitis
- GVHD greater than grade I GVHD of the skin
- No cytotoxics will be given within 4 weeks of administration of the investigational cell therapy
- Patients cannot receive any investigational agents within 30 days prior to administration of the investigational cell therapy
Sites / Locations
- Mount Sinai Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
Group 2
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
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)