NCT00002956

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 1996

Typical duration for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
Last Updated

March 21, 2016

Status Verified

November 1, 2012

Enrollment Period

5.3 years

First QC Date

November 1, 1999

Last Update Submit

March 18, 2016

Conditions

LeukemiaLymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent childhood lymphoblastic lymphomachildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomarecurrent/refractory childhood Hodgkin lymphomaT-cell large granular lymphocyte leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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

    baseline to x weeks post infusion

  • 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.

    baseline to x weeks past infusion

Study Arms (1)

infusions of EBV specific cytotoxic T lymphocytes

EXPERIMENTAL

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

Interventions

allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytesBIOLOGICAL
infusions of EBV specific cytotoxic T lymphocytes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaHodgkin DiseaseLymphoma, Large B-Cell, DiffuseRecurrenceLeukemia, Large Granular LymphocyticLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-CellLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellChronic Disease

Study Officials

  • Kenneth G. Lucas, MD

    University of Alabama at Birmingham

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 19, 2004

Study Start

November 1, 1996

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

March 21, 2016

Record last verified: 2012-11

Locations

US(1)