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



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

For Condition: post-transplant lymphoproliferative disorder
Status: Recruiting
Sponsor(s): University of Edinburg ,
Synopsis: 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: Randomizedphase 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DorothyCrawford,  Study Chair,  University of Edinburgh Medical School

King's College Hospital *Recruiting*
London,  England,  SE5 8RX
United Kingdom
Recruiting Ghulam  Mufti 44-20-7346-3080

Manchester Children's Hospitals (NHS Trust) *Recruiting*
Manchester,  England,  M27 SHA
United Kingdom
Recruiting N.  Webb 44-161-727-2435

University of Edinburgh Medical School *Recruiting*
Edinburgh,  Scotland,  EH8 9XD
United Kingdom
Recruiting Dorothy  Crawford 44-131-650-3142

Royal Infirmary of Edinburgh at Little France *Recruiting*
Edinburgh,  Scotland,  EH16 4SA
United Kingdom
Recruiting Alastair  MacGilchrist 44-131-536-1000

University of Edinburgh Laboratory for Clinical and Molecular Virology *Recruiting*
Edinburgh,  Scotland,  EH9 1QH
United Kingdom
Recruiting Tanzina  Haque 44-131-650-7941

Papworth Hospital *Recruiting*
Cambridge,  England,  CB3 8RE
United Kingdom
Recruiting Jayan  Parameshawar 44-1480-83-0541

Northern General Hospital *Recruiting*
Sheffield,  England,  S5 7AU
United Kingdom
Recruiting Peter  Braidley 44-114-243-4343

Institute of Cancer Research - UK *Recruiting*
Sutton,  England,  SM2 5NG
United Kingdom
Recruiting Anthony  Swerdlow 44-20-8722-4012

Royal Infirmary *Recruiting*
Glasgow,  Scotland,  G4 0SF
United Kingdom
Recruiting Andrew  Murday 44-141-211-4000

Royal Free and University College Medical School *Recruiting*
London,  England,  NW3 2PF
United Kingdom
Recruiting Peter  Amlot 44-20-7472-6205

Wythenshawe Hospital *Recruiting*
Manchester,  England,  M23 9LJ
United Kingdom
Recruiting A  Deiraniya 44-161-291-2565

Birmingham Children's Hospital *Recruiting*
Birmingham,  England,  B4 6NH
United Kingdom
Recruiting Deirdre  Kelly 44-121-333-9999


Additional Information:
Study ID Numbers:
  CDR0000069288;  CRUK-EBV-CTL,LCMV-CTL,EU-20057
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033475

Other Post-Transplant Lymphoproliferative Disorder Studies:
1. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder

2. Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation

3. Autologous Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

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

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