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

Sponsor:	University of Edinburgh
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00033475

Purpose

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.

Condition	Intervention	Phase
Lymphoproliferative Disorder	Biological: therapeutic allogeneic lymphocytes	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete response [ Designated as safety issue: No ]
Partial response [ Designated as safety issue: No ]
Stable disease [ Designated as safety issue: No ]
Progressive disease [ Designated as safety issue: No ]
Time to complete remission [ Designated as safety issue: No ]
Survival at 2 years [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2001

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033475

Locations

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

Sponsors and Collaborators

University of Edinburgh

Investigators

Study Chair:

Dorothy H. Crawford, MD

University of Edinburgh

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069288, CRUK-EBV-CTL, LCMV-CTL, EU-20057
Study First Received:	April 9, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00033475 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

post-transplant lymphoproliferative disorder

Additional relevant MeSH terms:

Lymphatic Diseases
Immunoproliferative Disorders
Pathologic Processes

Disease
Immune System Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 30, 2009