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

This study has been completed.
Sponsor:
Collaborators:
The Atlantic Philanthropies
Australian Department of Industry, Tourism and Resources
British Society for Haematology
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Maher Gandhi, Queensland Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00779337
First received: October 22, 2008
Last updated: May 21, 2012
Last verified: May 2012
History of Changes

October 22, 2008
May 21, 2012
October 2008
January 2012   (final data collection date for primary outcome measure)
  • Feasibility (generation of autologous clinical grade AdE1-LMP-specific CTL from the blood of EBV-positive lymphoma patients) [ Time Frame: The investigational product for each participant will be assessed post production. The patient will have blood samples taken prior to and following each infusion, and then at 1, 3, 6 & 12 months following the final infusion. ] [ Designated as safety issue: No ]
  • Safety as assessed by adverse event monitoring. Patients will be questioned and toxicities recorded according to the International Common Toxicity Criteria. [ Time Frame: 1 hour post 4 AdE1-LMP CTL injections (injections are weekly for first 10 participants & twice weekly for the next 10 participants), 3-5 weeks post the 4th injection, then 3, 6 and 12 months post the 4th injection ] [ Designated as safety issue: Yes ]
  • Reconstitution of EBV-specific CTL immunity with anti-viral efficacy measured by immunological & virological assessment of blood samples including immunophenotyping, intracellular cytokine assays, CD107 cytotoxicity assays and EBV DNA load analysis. [ Time Frame: At baseline, pre and 1 hour post 4 AdE1-LMP CTL injections, 3-5 weeks post the 4th injection, then 3, 6 and 12 months post the 4th injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00779337 on ClinicalTrials.gov Archive Site
  • Optimal dose intensity of the intervention. Clinical efficacy (radiological assessment by CT), biological efficacy (reconstitution of EBV-specific CTL immunity & anti-viral efficacy), safety & efficacy of the 1st treatment schedule vs the 2nd schedule [ Time Frame: Clinical evaluation, AE monitoring & collection of blood samples at baseline, pre & 1 hr post injections, 3-5 weeks, 3, 6 and 12 months post 4th injection. Radiological examination at baseline & at 3 to 5 wks & 3 months post the 4th treatment. ] [ Designated as safety issue: Yes ]
  • Clinical efficacy [ Time Frame: CT scan +/- additional scans at baseline , 3-5 weeks & 3 months post the 4th injection. Clinical evaluation at baseline, pre and 1 hour post injections, 3-5 weeks, 3, 6 and 12 months post the 4th injection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
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.
Experimental: Single group study
Autologous AdE1- Latent Membrane Protein (LMP) Cytotoxic T Lymphocytes.
Intervention: Biological: Autologous AdE1- Latent Membrane Protein CTLs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00779337
QIMR P1167, ANZCTR12608000521325
No
Maher Gandhi, Queensland Institute of Medical Research
Queensland Institute of Medical Research
  • The Atlantic Philanthropies
  • Australian Department of Industry, Tourism and Resources
  • British Society for Haematology
  • National Health and Medical Research Council, Australia
Principal Investigator: Maher K Gandhi, MB CHB PhD Queensland Institute of Medical Research
Queensland Institute of Medical Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP