Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL) (MABEL)
Hodgkin Disease, Non-Hodgkin Lymphoma, Severe Chronic Active Epstein Barr Virus
About this trial
This is an interventional treatment trial for Hodgkin Disease focused on measuring EBV positive diseases, cytotoxic T lymphocytes
Eligibility Criteria
Inclusion Criteria:
SCREENING
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
- Severe Chronic Active EBV (CAEBV) -- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
- Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.)
AND
- in first or subsequent relapse (Group A)
- with active disease persisting despite therapy (Group B)
- with active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group C)
- EBV positive tumor
- Weighs at least 12kg
- Informed consent (and assent as applicable) obtained from patient/guardian.
TREATMENT
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
- Severe Chronic Active EBV (CAEBV) -- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
- Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.)
AND
- in first or subsequent relapse (Group A)
- with active disease persist despite therapy (Group B)
- with active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group C)
- EBV positive tumor
- Patients with life expectancy greater than or equal to 6 weeks
- Patients with bilirubin less than or equal to 3x upper limit of normal
- AST less than or equal to 5x upper limit of normal
- Hemoglobin greater than or equal to 7.0 (may be a transfused value)
- Patients with a creatinine less than or equal to 2x upper limit of normal for age
- Pulse oximetry of > 90% on room air
- Patients should have been off other investigational therapy for 30 days prior to infusion.
- Patients with a Karnofsky/Lansky score of more than or equal to 50.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Informed consent (and assent as applicable) obtained from patient/guardian.
Exclusion Criteria:
TREATMENT
- Pregnant or lactating
- Severe intercurrent infection
- Current use of systemic corticosteroids more than 0.5 mg/kg/day
- Patients receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days.
Sites / Locations
- Houston Methodist HospitalRecruiting
- Texas Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A: MABEL CTLs
Group B: MABEL CTLs
Group C: MABEL CTLs
Patients with 1st or subsequent relapse. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Patients with persistent active disease despite therapy. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
Patients with active disease if immunosuppressive chemotherapy is contraindicated. Three different dosing schedules will be evaluated. Two to four patients will be evaluated on each dosing schedule. Each patient will receive 2 injections, 14 days apart. If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.