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Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002956
Recruitment Status : Withdrawn
First Posted : July 19, 2004
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham

Study Description
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Brief Summary:

RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.

PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes Phase 1

Detailed Description:

OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.

OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.

PROJECTED ACCRUAL: 10 patients will be accrued in this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients
Study Start Date : November 1996
Actual Primary Completion Date : February 2002
Actual Study Completion Date : February 2002

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: infusions of EBV specific cytotoxic T lymphocytes
Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression
 Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients [ Time Frame: baseline to x weeks post infusion ]
  2. Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions. [ Time Frame: baseline to x weeks past infusion ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy
  • following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin
  • At least 4 weeks
  • Patients serologically hepatitis B and C positive may receive cytotoxic
  • T- lymphocytes (CTL) from donors who are serologically positive for the same virus
  • Must have an HLA identical or HLA haploidentical donor

Exclusion

  • hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present)
  • Bilirubin less than 2.0 mg/dL
  • renal dysfunction
  • Creatinine clearance at greater than 50 mL/min
  • cardiac dysfunction
  • neurologic dysfunction
  • pulmonary dysfunction
  • patients developing EBV LPD who have a donor origin lymphoma
  • HIV-1 positive
  • Not capable of undergoing leukapheresis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002956


Locations
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United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Study Chair: Kenneth G. Lucas, MD University of Alabama at Birmingham
More Information
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Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00002956    
Other Study ID Numbers: CDR0000065433
UAB-9739
IUMC-9611-37
NCI-V97-1176
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: November 2012
Keywords provided by University of Alabama at Birmingham:
recurrent adult Hodgkin lymphoma
recurrent childhood lymphoblastic lymphoma
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
T-cell large granular lymphocyte leukemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
 recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases