Chronic Lymphocytic Lymphoma, Hodgkin's Disease, Multiple Myeloma, Relapsed Non-Hodgkin's Lymphoma
Conditions
Keywords
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)
Brief 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.
Interventions
BIOLOGICALMSSM/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).
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactKeren Osman, MD
Backup ContactLinda Sacris, RN
Outcome results
None listed