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

Lymphoproliferative Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00033475
• Other study ID #: CDR0000069288
• Secondary ID: CRUK-EBV-CTLLCMV
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 9, 2002
• Last updated: December 18, 2013
• Start date: March 2001

Study information

• Verified date: June 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoproliferative Disorder
• Lymphoproliferative Disorders

Intervention

Biological:
• therapeutic allogeneic lymphocytes

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Papworth Hospital	Cambridge	England
United Kingdom	Royal Infirmary of Edinburgh at Little France	Edinburgh	Scotland
United Kingdom	University of Edinburgh	Edinburgh	Scotland
United Kingdom	University of Edinburgh Laboratory for Clinical and Molecular Virology	Edinburgh	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	King's College Hospital	London	England
United Kingdom	Royal Free and University College Medical School	London	England
United Kingdom	Central Manchester and Manchester Children's University Hospitals NHS Trust	Manchester	England
United Kingdom	Wythenshawe Hospital	Manchester	England
United Kingdom	Northern General Hospital	Sheffield	England
United Kingdom	Institute of Cancer Research - UK	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response			No
Primary	Partial response			No
Primary	Stable disease			No
Primary	Progressive disease			No
Primary	Time to complete remission			No
Primary	Survival at 2 years			No