Status:
COMPLETED
Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas
Lead Sponsor:
Queensland Institute of Medical Research
Collaborating Sponsors:
The Atlantic Philanthropies
Australian Department of Industry, Tourism and Resources
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00779337
Start Date
October 1 2008
End Date
May 1 2012
Last Update
May 22 2012
Active Locations (1)
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1
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102