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

Phase 3

• Conditions: Lymphoproliferative Disorder

• Registration Number: NCT00033475
• Lead Sponsor: University of Edinburgh

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.

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 Timeline

• Study Start: 2001-03
• Study First Submitted: 2002-04-09
• Status Verified: 2002-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response
Survival at 2 years
Partial response
Time to complete remission
Stable disease
Progressive disease

Trial Locations

Locations (12)

Birmingham Children's Hospital; 🇬🇧 Birmingham, England, United Kingdom

Royal Free and University College Medical School; 🇬🇧 London, England, United Kingdom

King's College Hospital; 🇬🇧 London, England, United Kingdom

University of Edinburgh Laboratory for Clinical and Molecular Virology; 🇬🇧 Edinburgh, Scotland, United Kingdom

Royal Infirmary of Edinburgh at Little France; 🇬🇧 Edinburgh, Scotland, United Kingdom

Papworth Hospital; 🇬🇧 Cambridge, England, United Kingdom

Northern General Hospital; 🇬🇧 Sheffield, England, United Kingdom

Central Manchester and Manchester Children's University Hospitals NHS Trust; 🇬🇧 Manchester, England, United Kingdom

Institute of Cancer Research - UK; 🇬🇧 Sutton, England, United Kingdom

Royal Infirmary - Castle; 🇬🇧 Glasgow, Scotland, United Kingdom

Wythenshawe Hospital; 🇬🇧 Manchester, England, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom