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

Withdrawn before enrolling · Phase 2

Conditions studied: Hodgkin Lymphoma, Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT02115126

Run by

David Rizzieri, MD

People needed

0

Starts

2016-12-01

Expected to finish

2025-01-01

Last updated by the study team

2016-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each patient must meet all of the following inclusion criteria:
• Patient must have a histologically proven diagnosis of any EBV+ Hodgkin or non-Hodgkin lymphoma
• EBV positive will be defined as positive if LMP1 or 2 or EBER are positive. As long as EBV positive on a prior biopsy, EBV testing will not be required at the time of relapse. However, if EBV testing performed on a more recent biopsy and it is negative, that patient will be excluded.
• Patients must have had persistent, relapsed, or refractory disease to at least one prior regimen with plans to proceed to autologous stem cell transplant
• Patients must be in a complete remission at time of initial pheresis for vaccine preparation; complete remission will be determined using Cheson Criteria100
• There are no limits on the number of prior therapies allowed
• Able to give voluntary written informed consent
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study therapy and for 3 months after vaccine #2.
• Male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 3 months after vaccine #2.
• Patients must be 18 years of age or older.
• ECOG performance status 0-2.

You may not qualify if…

• An estimated or measured creatinine clearance of less than 30 ml/min.
• AST, ALT, total bilirubin > 3 times the upper limit of normal
• Patients on chronic immunosuppressive therapy for any reason (other than chemotherapy for HL)
• Chronic systemic steroid therapy at doses greater than 10mg/day of prednisone or its equivalent.
• Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result within 48 hours of enrollment. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Patient has received other investigational drugs for this disease within 14 days of enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Patients who are HIV positive AND have a CD4 count <50
• Prior solid organ transplant or allogeneic stem cell transplant

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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