EBV Associated Lymphoma Clinical Trial
Official title:
Open-Label Individual Patient Study of Epstein-Barr Virus (EBV) Specific T-Cell Lines for the Treatment of a Lymphoproliferative Disease and Hemophagocytic Syndrome Associated With EBV
Single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic EBV-positive lymphoma of childhood.
Status | Recruiting |
Enrollment | 1 |
Est. completion date | April 5, 2025 |
Est. primary completion date | April 5, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Capacity to provide informed consent 2. Age = 18 3. Negative serum pregnancy test and use of effective contraception method. Exclusion Criteria: 1. Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3, Campath) 2. Pregnancy 3. Any abnormal condition or laboratory result that is considered by the Principal Investigator capable of altering patient or study outcome. 4. Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic GVHD) at time of enrolment or infusion. |
Country | Name | City | State |
---|---|---|---|
Canada | Ciusss-Emtl | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of a donor-derived EBV-specific T-cell line as assessed clinically by the lack of graft-versus-host host (GVHD). | Evaluate the safety in terms of occurrence of graft-versus-host disease of a donor-derived allogeneic EBV-specific T-cell line generation and infusion in a patient suffering from a life-threatening EBV-related disease who received an allogeneic stem cell transplantation. Acute GVHD symptoms will be scored using MAGIC criteria using scores from 0 to IV, IV being the most severe involvement) on skin, liver and gastro-intestinal tract. Chronic GVHD symptoms will be score using the NIH consensus scale (0 to 3, 3 being the most severe) on the following organs skin, mouth, eyes, GI tract, liver, lungs, joints and fascia, and genital tract. | 1 year | |
Secondary | Clinical response | Disease recurrence as assessed by imaging (PET scanning) | 1 year | |
Secondary | Immune reconstitution to EBV | Measurement of viral titers (nucleic acid testing) and peripheral blood ELISpot measurements | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05011058 -
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
|
Phase 2 | |
Active, not recruiting |
NCT01823718 -
Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
|
Phase 1 |