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

Phase 1

Completed

• Conditions: Relapsed or refractory EBV-positive lymphoma; Blood - Haematological diseases

• Registration Number: ACTRN12608000521325
• Lead Sponsor: Queensland Institute of Medical Research (QIMR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified