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3rd Party LMP1/2-Specific Cytotoxic T Lymphocytes for EBV-Associated Lymphoma

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Mitchell Cairo, New York Medical College
Sponsor:
Collaborators:
Children's Research Institute
Baylor College of Medicine
M.D. Anderson Cancer Center
University of Michigan
University of Utah
City of Hope Medical Center
Ohio University
Johns Hopkins University
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College
ClinicalTrials.gov Identifier:
NCT02057445
First received: February 5, 2014
Last updated: October 4, 2016
Last verified: October 2016
  Purpose
The administration of allogeneic third party derived LMP specific-CTLs (special peripheral blood cells from another person) that are made specific to fight EBV infection) in Children, Adolescents and Young Adults (CAYA) with EBV-associated refractory or relapsed lymphoma will be feasible ( able to be done), safe and well tolerated (no unexpected serious events will occur). In addition, potential donors who are EBV positive will be enrolled to donate peripheral blood to help build a bank of these specific EBV fighting cell lines.

Condition Intervention Phase
Non-Hodgkins Lymphoma Hodgkins Lymphoma Lymphoproliferative Disorder Drug: EBV CTL's Other: Peripheral Blood Donor Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Pilot Study of Third Party LMP1/2-Specific Cytotoxic T Lymphocytes for Treatment of Patients With Refractory /Relapsed EBV-Associated Lymphoma A Childhood, Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) Multicenter Clinical Trial

Resource links provided by NLM:


Further study details as provided by Mitchell Cairo, New York Medical College:

Primary Outcome Measures:
  • To determine the safety of giving 3rd party EBV-CTLs [ Time Frame: 1 year ]
    Patients will be monitored for any unexpected adverse events related to investigational product.

  • To develop a third party bank of LMP-specific CTL [ Time Frame: on going ]
    EBV positive donors will be asked to provide an extra sample of peripheral blood to build a donor bank of EBV-CTLs for this protocol and future use.


Secondary Outcome Measures:
  • To measure the response rate [ Time Frame: 1 year ]
    patients will be followed a year following administration of cells for disease response.


Estimated Enrollment: 18
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recipient
EBV+ patients will receive 3rd party LMP-CTLs for treatment of EBV infection and/or disease
Drug: 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.
Other: 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

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 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:

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 LMP/CTL protocol.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057445

Contacts
Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, RN 617-285-7844 lauren_harrison@nymc.edu

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States
Contact: Catherine Bollard, MD    202-476-5000    cbollard@childrensnational.org   
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Lauren Harrison, RN    6172857844    lauren_harrison@nymc.edu   
Sponsors and Collaborators
New York Medical College
Children's Research Institute
Baylor College of Medicine
M.D. Anderson Cancer Center
University of Michigan
University of Utah
City of Hope Medical Center
Ohio University
Johns Hopkins University
Investigators
Principal Investigator: Mitchell Cairo, MD New York Medical College
Principal Investigator: Catherine Bollard, MD Children's Research Institute
  More Information

Responsible Party: Mitchell Cairo, Principal Investigator, New York Medical College
ClinicalTrials.gov Identifier: NCT02057445     History of Changes
Other Study ID Numbers: NYMC-561
Study First Received: February 5, 2014
Last Updated: October 4, 2016

Keywords provided by Mitchell Cairo, New York Medical College:
cellular therapy
lymphoma
lymphoproliferative disorder

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 23, 2017