EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma (CILESTE)
EBV-Related Hodgkin Lymphoma, Lymphoproliferative Disorders, EBV Related Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for EBV-Related Hodgkin Lymphoma focused on measuring non-Hodgkin's Lymphoma, EBV (associated)-T/NK-lymphoproliferative disease, EBV SPECIFIC T-LYMPHOCYTES, EBV, Hodgkin's Lymphoma, lymphoma relapse
Eligibility Criteria
INCLUSION CRITERIA AT TIME OF PROCUREMENT
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T/NK-lymphoproliferative disease who may subsequently be eligible for the treatment component
- EBV positive tumor (can be pending)
- Weighs at least 10 kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
INCLUSION CRITERIA AT TIME OF INFUSION
1) Any patient regardless of age or sex, with diagnosis of either
- EBV positive Hodgkin's lymphoma
- EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
- EBV (associated)-T/NK-lymphoproliferative disease
AND either
A) In first or subsequent relapse or with persistent active disease despite therapy; OR
B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL.
2) EBV positive tumor confirmed by pathology
3) Patients with life expectancy ≥ 6 weeks
4) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 5x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value)
5) Pulse oximetry of >90% on room air
6) Patients should have been off other investigational therapy for 4 weeks prior to entry in this study.
7) Patients with a Karnofsky/Lansky score of ≥ 50
8) Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given a copy of informed consent.
EXCLUSION CRITERIA AT TIME OF PROCUREMENT
1. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
EXCLUSION CRITERIA AT TIME OF INFUSION
- Pregnant or breastfeeding
- Active and uncontrolled bacterial, viral or fungal infection
- Current use of systemic corticosteroids (prednisone equivalent >0.5 mg/kg/day)
- Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
Sites / Locations
- Houston Methodist HospitalRecruiting
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A: Treatment without lymphodepletion chemotherapy
Arm B: Treatment with lymphodepletion chemotherapy
C7R-EBVSTs Group B will be activated if only limited expansion and clinical efficacy is observed in Group A
C7R-EBVSTs with lymphodepletion chemotherapy