Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	CRUK-EBV-CTL LCMV-CTL, EU-20057, NCT00033475

Objectives

1. 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.

Entry Criteria

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

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

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

Expected Enrollment

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

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

University of Edinburgh Laboratory for Clinical and Molecular Virology

Dorothy Crawford, MD, Protocol chair		Ph: 44-131-650-3142

Registry Information
Official Title		Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients
Trial Start Date		2001-03-01
Registered in ClinicalTrials.gov		NCT00033475
Date Submitted to PDQ		2002-02-05
Information Last Verified		2002-06-14

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