NCT00033475

Brief Summary

RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus. Combining reduced immunosuppressive therapy with donor white blood cells that have been treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective treatment for lymphoproliferative disease. PURPOSE: Randomized phase III trial to compare the effectiveness of reducing immunosuppressive therapy with or without donor white blood cells in treating patients who have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

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

March 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 15, 2026

Status Verified

September 1, 2025

First QC Date

April 9, 2002

Last Update Submit

January 13, 2026

Conditions

Lymphoproliferative Disorder

Keywords

post-transplant lymphoproliferative disorder

Outcome Measures

Primary Outcomes (6)

  • Complete response

  • Partial response

  • Stable disease

  • Progressive disease

  • Time to complete remission

  • Survival at 2 years

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

Eligibility Criteria

Age0 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation * Epstein-Barr virus-positive tumor * Newly diagnosed disease * Measurable disease by clinical methods or radiography * Must have partially matched donor cytotoxic T cells (CTL) available * No known panel reactivity to any of the HLA types of CTL available for therapy PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Karnofsky 20-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior therapy for PTLD * No concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for PTLD

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Papworth Hospital

Cambridge, England, CB3 8RE, United Kingdom

Location

Royal Free and University College Medical School

London, England, NW3 2PF, United Kingdom

Location

King's College Hospital

London, England, SE5 8RX, United Kingdom

Location

Wythenshawe Hospital

Manchester, England, M23 9LJ, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Northern General Hospital

Sheffield, England, S5 7AU, United Kingdom

Location

Institute of Cancer Research - UK

Sutton, England, SM2 5NG, United Kingdom

Location

Royal Infirmary of Edinburgh at Little France

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

University of Edinburgh

Edinburgh, Scotland, EH8 1QH, United Kingdom

Location

University of Edinburgh Laboratory for Clinical and Molecular Virology

Edinburgh, Scotland, EH9 1QH, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Lymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Dorothy H. Crawford, MD

    University of Edinburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

March 1, 2001

Last Updated

January 15, 2026

Record last verified: 2025-09

Locations

GB(12)