Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation

December 18, 2013 updated by: University of Edinburgh

Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy of treatment with partially HLA-matched allogeneic cytotoxic T cells and reduction of immunosuppression, in terms of survival rate and time to remission in patients with Epstein-Barr virus-associated B-cell lymphoproliferative disease after solid organ transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to transplanted organ type and transplant center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5 regimens at physician's discretion. Patients then receive partially HLA-matched allogeneic cytotoxic T cells IV over 5 minutes once weekly for a total of 4 weeks.
  • Arm II: Patients undergo reduction of immunosuppression as in arm I alone. Patients are followed monthly for 6 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Birmingham Children's Hospital
      • Cambridge, England, United Kingdom, CB3 8RE
        • Papworth Hospital
      • London, England, United Kingdom, SE5 8RX
        • King's College Hospital
      • London, England, United Kingdom, NW3 2PF
        • Royal Free and University College Medical School
      • Manchester, England, United Kingdom, M23 9LJ
        • Wythenshawe Hospital
      • Manchester, England, United Kingdom, M27 4HA
        • Central Manchester and Manchester Children's University Hospitals NHS Trust
      • Sheffield, England, United Kingdom, S5 7AU
        • Northern General Hospital
      • Sutton, England, United Kingdom, SM2 5NG
        • Institute of Cancer Research - UK
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh at Little France
      • Edinburgh, Scotland, United Kingdom, EH8 1QH
        • University of Edinburgh
      • Edinburgh, Scotland, United Kingdom, EH9 1QH
        • University of Edinburgh Laboratory for Clinical and Molecular Virology
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Royal Infirmary - Castle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Stable disease
Complete response
Survival at 2 years
Partial response
Progressive disease
Time to complete remission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • Study Chair: Dorothy H. Crawford, MD, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Registration Dates

First Submitted

April 9, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

June 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069288
  • CRUK-EBV-CTL
  • LCMV-CTL
  • EU-20057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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