Clincosm LogoSign in Get a demo

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

Sponsor
University of Edinburgh (Other)
Overall Status
Unknown status
CT.gov ID
NCT00033475
Collaborator
(none)
50
Enrollment
12
Locations
4.2
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: therapeutic allogeneic lymphocytes
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients
Study Start Date :
Mar 1, 2001

Outcome Measures

Primary Outcome Measures

  1. Complete response []

  2. Partial response []

  3. Stable disease []

  4. Progressive disease []

  5. Time to complete remission []

  6. Survival at 2 years []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

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

Sponsors and Collaborators

  • University of Edinburgh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00033475
Other Study ID Numbers:
  • CDR0000069288
  • CRUK-EBV-CTL
  • LCMV-CTL
  • EU-20057
First Posted:
Jan 27, 2003
Last Update Posted:
Dec 19, 2013
Last Verified:
Jun 1, 2002
Keywords provided by , ,
post-transplant lymphoproliferative disorder
Additional relevant MeSH terms:
Lymphoproliferative Disorders

Study Results

No Results Posted as of Dec 19, 2013