Trial | NCT00779337  Report issue

Official Title

Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
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.
Study Started
Oct 31
2008
Primary Completion
Jan 31
2012
Study Completion
May 31
2012
Last Update
May 22
2012
Estimate

Biological Autologous AdE1- Latent Membrane Protein CTLs

Total dose 20-800 million CTL given in 4 equal doses (5-200 million CTL) given intravenously, at weekly intervals for the first cohort of 10 patients and twice a week for the second cohort of 10 patients.

Single group study Experimental

Autologous AdE1- Latent Membrane Protein (LMP) Cytotoxic T Lymphocytes.

Criteria 

Inclusion Criteria:

Informed consent.
EBV-positive lymphoma as determined by in situ hybridization or equivalent (excluding Burkitts Lymphoma).
Age 18 years or older.
ECOG performance status 1, 2 or 3
Life expectancy of at least 6 months.
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.
No chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to anticipated date of first infusion.

Exclusion Criteria:

EBV negative tumour
Presence of detectable malignant cells in the peripheral circulation by flow cytometry or morphology
Serious infection within the past 28 days that has not adequately responded to therapy
Pregnancy, or unwilling to use adequate contraception
Serology (taken within 3 months of CTL release date) indicating active HBV or HCV infection, positive serology for HIV I&II, HTLV1 or syphilis
Negative serology for EBV
Psychiatric, addictive or any condition which may compromise the ability to participate in this trial
No Results Posted