Epstein-Barr Virus (EBV) -specific T cells as therapy for relapsed / refractory EBV-positive lymphomas

Epstein-Barr Virus (EBV)-specific T cells as therapy for relapsed/refractory EBV-positive lymphomas

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000521325

Acronym

EPL

Enrollment

Registered

2008-10-13

Start date

2008-10-23

Completion date

2011-09-21

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will use a new method of treating lymphoma using a therapy derived from a person’s Killer T cells. These Killer T cells are taken from a person's blood and grown in a test tube to increase the number of these cells that are specifically active against the lymphoma cells. The cells are then given to the patient by intravenous infusion with the aim of killing the lymphoma cells. Potentially this treatment will help to kill the residual/recurrent tumour that is present after other lymphoma treatment and reduce the chance of the tumour recurring.

Interventions

Autologous AdE1-Latent Membrane Protein (LMP) Cytotoxic T Lymphocytes. Dose, duration and mode of administration: total dose 20-800 million CTL given in 4 equal doses (each dose 5-200 million CTL) intravenously, at weekly intervals for the first cohort of 10 patients, and twice a week for the second cohort of ten patients.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1 Informed consent. 2 EBV-positive lymphoma as determined by in situ hybridization or equivalent (excluding Burkitts Lymphoma). 3 Age 18 years or older. 4 Eastern Cooperative Oncology Group (ECOG) performance status 1, 2 or 3 5 Life expectancy of at least 6 months. 6 Measurable disease: either relapsing, partially responsive, refractory or progressive disease, includes disease detected either by clinical examination, radiographic evaluation (including CT scans, and at physician’s discretion by functional imaging), or a persistently detectable plasma EBV viral load. 7 No chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to anticipated date of first infusion.

Exclusion criteria

1 EBV negative tumour. 2 Presence of detectable malignant cells in the peripheral circulation by flow cytometry or morphology. 3 Serious infection within the past 28 days that has not adequately responded to therapy. 4 Pregnancy, or unwilling to use adequate contraception. 5 Serology (taken within 3 months of CTL release date) indicating active HBV or HCV infection, positive serology for HIV I&II, HTLV1 or syphilis. 6 Negative serology for EBV. 7 Psychiatric, addictive or any condition which may compromise the ability to participate in this trial

Outcome results