Patient must be at least 1 year of age.
Patient or the patient's legally authorized guardian must be fully informed about their
illness and the investigational nature of the study protocol (including foreseeable risks
and possible side effects), and must sign an informed consent in accordance with the
institutional policies approved by the U.S. Department of Health and Human Services.
Patients should have been off other investigational therapy for one month prior to entry
in this study.
Patient must have adequate organ function as below:
Adequate renal function defined as:
- Serum creatinine <2.0 x normal, or
- Creatinine clearance or radioisotope GFR > 40 ml/min/m2 or >60 ml/min/1.73 m2 or an
equivalent GFR as determined by the institutional normal range
Adequate liver function defined as:
- Total bilirubin <2.0 x normal; and
- SGOT (AST) or SGPT (ALT) <5.0 x normal
Adequate pulmonary function defined as:
- Pulse oximetry >94% in room air. Lansky (< 16yr) or Karnofsky (> 16 yrs) performance
status 50% Life expenctancy 6 weeks. Women of child bearing age require a negative
urine pregnancy test. Clinical status at enrollment to allow tapering of steroids to less
than 0.5mg/kg/day prednisone at time of treatment.
4.5 Disease Status (Eligibility) 4.5.1 Any patient, with one or more of the following
EBV-positive type II latency or associated disorders, regardless of the histological
subtype: Hodgkin lymphoma Non-Hodgkin lymphoma Lymphoproliferative disorder Severe chronic
active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC
(> 4000 genomes per g PBMC DNA) and/or biopsy tissue positive for EBV
The disease needs to be in one of the following stages:
At diagnosis who would be unable to receive conventional chemotherapy or in first relapse
AND the patient is not a candidate for HSCT Partial response after conventional therapy.
Refractory to conventional therapy for his/her condition. In second or subsequent relapse.
Residual disease after autologous, syngeneic or allogeneic HSCT.
All patients entered into the study ideally will have tumor tissue from the original
diagnostic specimen and/or relapse reviewed centrally for confirmation of EBV positive
disease. If no specimen is available, local pathology report documenting EBV positivity is
acceptable. Appropriate immunophenotyping to confirm the diagnosis will be performed. In
addition, in situ hybridization for EBV (LMP1, and/or EBER positivity) will be performed.
All central morphologic analysis and immunohistochemical/insitu hybridization staining
will be performed in the laboratory of Sherrie Perkins and Rodney Miles at the University
Donor Eligibility for LMP-CTL Third Party Banking (Aim 2.1.2)
- Donor must be HIV negative.
- Donors must have adequate hematopoietic function defined as absolute neutrophil count
> 1000/mm3, hemoglobin > 10 g/dl, and platelet count >50,000/mm3 and be EBV IgG
- Donors will have peripheral blood collected for LMP specific CTL production. A
minimum of 60 cc of peripheral blood x 2 for a total maximum amount of blood of
120cc, will be collected from the donor (subjects must be at least 12 kg or 24
pounds). (See Appendix B) For donors <18 years a maximum of 3cc/kg blood will be
taken in an 8 week period.
- For donors that are to undergo stem cell collection, the peripheral blood for LMP
specific CTL production will be collected prior to the stem cell collection and
without a specific day specification.
- Donor eligibility must meet criteria as per 21 CFR 1271.
Currently receiving any investigational agents or have received any tumor vaccines within
previous 4 weeks.
Active acute grade III-IV graft-versus-host disease. Severe refractory intercurrent
infection other than EBV. Received alemtuzumab or other anti-Tcell antibody within 28
days. HIV seropositivity. Pregnancy (due to unknown effects of this therapy on a fetus) or
lactation. Patients with PTLD post solid organ transplantation eligible for the COG PTLD
Minimum Eligible Age: 1 Year
Maximum Eligible Age: N/A
Eligible Gender: Both