3rd Party LMP1/2-Specific Cytotoxic T Lymphocytes for EBV-Associated Lymphoma
NCT ID: NCT02057445
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recipient
EBV+ patients will receive 3rd party LMP-CTLs for treatment of EBV infection and/or disease
EBV CTL's
Eligible patients with a matched cell line will be infused with 3rd party CTLs and monitored for adverse events and response. Patients who show a response and tolerate the infusion well may receive up to 5 infusions total 4-6 weeks apart.
Donor
Healthy donors who are EBV+ will be asked to donate 60-120 ml of peripheral blood for development of cell lines to be stored for cell line bank.
Peripheral Blood Donor
Donors who are EBV+ and meet the eligibility criteria will be consented to provide 60-120 ml peripheral blood once for future use for this and other clinical trials using 3rd party CTLs.
Interventions
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EBV CTL's
Eligible patients with a matched cell line will be infused with 3rd party CTLs and monitored for adverse events and response. Patients who show a response and tolerate the infusion well may receive up to 5 infusions total 4-6 weeks apart.
Peripheral Blood Donor
Donors who are EBV+ and meet the eligibility criteria will be consented to provide 60-120 ml peripheral blood once for future use for this and other clinical trials using 3rd party CTLs.
Eligibility Criteria
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Inclusion Criteria
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 μg 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 of Utah.
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 seropositive.
* 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.
Exclusion Criteria
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 LMP/CTL protocol.
1 Year
ALL
Yes
Sponsors
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Children's National Research Institute
OTHER
Baylor College of Medicine
OTHER
M.D. Anderson Cancer Center
OTHER
University of Michigan
OTHER
University of Utah
OTHER
City of Hope Medical Center
OTHER
Ohio University
OTHER
Johns Hopkins University
OTHER
New York Medical College
OTHER
Responsible Party
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Mitchell Cairo
Principal Investigator
Principal Investigators
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Mitchell Cairo, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Catherine Bollard, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Medical Center
Washington D.C., District of Columbia, United States
New York Medical College
Valhalla, New York, United States
Countries
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Other Identifiers
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NYMC-561
Identifier Type: -
Identifier Source: org_study_id