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Phase II Trial to Evaluate an EBV-derived Dendritic Cell Vaccine in Autologous Stem Cell Transplant

NCT02115126 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-11-01

No results posted yet for this study

Summary

This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the setting of autologous stem cell transplant with infusion of mature T cells. Patients will be randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand, DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and non-Hodgkin lymphoma.

Conditions

Interventions

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.

BIOLOGICAL

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.

Sponsors & Collaborators

  • David Rizzieri, MD

    lead OTHER

Principal Investigators

  • Anne Beaven, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-01-31
Completion
2025-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115126 on ClinicalTrials.gov