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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


Phase 1
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: 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 orgin

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Patients serologically
hepatitis B and C positive may receive cytotoxic T lymphocytes (CTL) from donors who are
serologically positive for the same virus No 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: No renal dysfunction Creatinine clearance at least 50 mL/min Cardiovascular:
No cardiac dysfunction Neurologic: No neurologic dysfunction Pulmonary: No pulmonary
dysfunction Other: (patient) Must have an HLA identical or HLA haploidentical donor No
patients developing EBV LPD who have a donor origin lymphoma Patients serologically
positive for cytomegalovirus positive may receive CTL from donors who are serologically
positive for the same virus (donor) Not HIV-1 positive Medically fit to undergo
leukapheresis Donor CTL must be capable of lysing patient B lymphoblastoid cell line
(BLCL) in vitro

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth G. Lucas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000065433

NCT ID:

NCT00002956

Start Date:

November 1996

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294