Phase II Trial to Evaluate an EBV-derived Dendritic Cell Vaccine in Autologous Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02115126|
Recruitment Status : Withdrawn
First Posted : April 15, 2014
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma Non-Hodgkin Lymphoma||Biological: LMP2A-loaded conventional DC vaccine Biological: DUK-CPG-001||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial to Evaluate an EBV Derived Dendritic Cell (DC) Vaccine When Administered Alone or Co-administered With the TLR9 Agonist, DUK-CPG-001, in EBV+ Lymphoma in the Setting of Autologous Stem Cell Transplant|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2025|
Active Comparator: LMP2A-loaded conventional DC vaccine
Epstein-Barr virus (EBV) derived tumor antigen, LMP2 loaded DC vaccine
Biological: LMP2A-loaded conventional DC vaccine
Vaccine #1 will be administered 9-13 weeks status post peripheral blood stem cell (PBSC) infusion. At the time of vaccination, ANC must be > 1.5.
Vaccine #2, the booster vaccine, will be administered 4 weeks +/- 7 days status post vaccine #1. At the time of vaccination, ANC must be > 1.5.
Vaccines will be administered following standard institutional practice for IV infusions using a peripheral or central line and following sterile technique. On the day of vaccination, the patient will be given a total dose of 3 x 107 cells in 30ml of normal saline per vaccination.
Experimental: LMP2A-loaded DC vaccine + DUK-CPG-001
Epstein-Barr virus (EBV) derived tumor antigen, LMP2 loaded DC vaccine co-administered with a Toll-like receptor 9 (TLR9) ligand, DUK-CPG-001
On the day of vaccination, for those patients who are randomized to receive DUK-CPG-001, a single vial will be dispensed to the nurse, upon request, by Duke ICS. DUK-CPG-001 will be thawed at room temperature right before use and 0.5 ml (5 mg) will be injected subcutaneously immediately after vaccination.
DUK-CPG-001 will be stored at -20ºC until use. It will be stored in the Duke Investigational Chemotherapy Service pharmacy.
Using standard institutional guidelines and sterile technique for subcutaneous injections, 5 mg of DUK-CPG-001 will be injected subcutaneously immediately after each vaccination.
- Immune response [ Time Frame: 7 days post 2nd vaccination ]
Immune response will be defined as an increase in number of spots to 25-fold more than at baseline, and at least 200 spots per 105 cluster of differentiation 8 (CD8)+ T cells, by Day 7 post 2nd vaccination (i.e., a patient with a baseline of 1 spot/105 CD8+ T cells who achieved 25 spots/million would not be counted as a response).
"Spots" are the readout for immune activation measured by the enzyme-linked immunosorbent spot (ELISPOT) assay. Each spot is indicative of an activated T cell that secrete interferon (IFN)-gamma, a cytokine produced by activated T cells.
- Number of patients with greater than grade 1 toxicity [ Time Frame: 30 days post last dose of vaccine ]
- Duration of the presence of long term memory cells [ Time Frame: 7 days post second dose of vaccine ]
- Duration of multi-functional CD8 T cell responses [ Time Frame: 7 days post second dose of vaccine ]
- Duration of Th1, Th2 and Th17 cluster of differentiation 4 (CD4) T cell responses as well as CD4+cluster of differentiation 25 (CD25)+Foxp3+ regulatory T cell (Treg) responses [ Time Frame: 7 days post second dose of vaccine ]
- Disease free survival [ Time Frame: up to 10 years ]Number of days from PBSC transplant until disease relapse or death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115126
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Anne Beaven, MD||Duke University|