Birmingham, Alabama 35294

  • Lymphoma

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000065433


NCT ID:

NCT00002956


Secondary ID:

UAB-9739


Study Acronym:


Brief Title:

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


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


Overall Status:

Withdrawn


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kenneth G. Lucas, MD
Study Chair
University of Alabama at Birmingham

Study Dates

Start Date:November 1996
Completion Date:February 2002
Completion Type:Actual
Primary Completion Date:February 2002
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:March 18, 2016
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:allogeneic Epstein-Barr virus-specific cytotoxic T
Arm Name:infusions of EBV specific cytotoxic T lymphocytes

Study Arms

Study Arm Type:Experimental
Arm Name:infusions of EBV specific cytotoxic T lymphocytes
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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