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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Trial status: Active, Not Recruiting to Completed
    • Start date: Mar 2001 to Mar 1, 2001
    v18
  2. Lead sponsor: National Cancer Institute (NCI) to University of Edinburghv17
  3. Lead sponsor: University of Edinburgh to National Cancer Institute (NCI)v16
  4. Interventions: therapeutic allogeneic lymphocytes (Drug) to therapeutic allogeneic lymphocytes (Biological)v15
  5. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv13-v14
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  1. Interventions: peripheral blood lymphocyte therapy (Procedure), therapeutic allogeneic lymphocytes (Drug) to therapeutic allogeneic lymphocytes (Drug)v12
  2. Re-verified, no change to tracked fieldsv11
  3. Interventions: biological therapy (Procedure), leukocyte therapy (Procedure), peripheral blood lymphocyte therapy (Procedure), therapeutic allogeneic… to peripheral blood lymphocyte therapy (Procedure), therapeutic allogeneic lymphocytes (Drug)v10
  4. Study Status, Outcome Measuresv9
  5. Interventions: allogeneic lymphocytes (Drug), biological therapy (Procedure), leukocyte therapy (Procedure), peripheral blood lymphocyte therapy… to biological therapy (Procedure), leukocyte therapy (Procedure), peripheral blood lymphocyte therapy (Procedure), therapeutic allogeneic…v8
  6. Enrollment target: 50
    • Start date: Mar 2001
    • Interventions: EBV-specific cytotoxic T-lymphocytes (Drug), biological therapy (Procedure), leukocyte therapy (Procedure), peripheral blood lymphocyte… to allogeneic lymphocytes (Drug), biological therapy (Procedure), leukocyte therapy (Procedure), peripheral blood lymphocyte therapy…
    v7
  7. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 12 of 12 sites
    v6
  8. Re-verified, no change to tracked fieldsv5
  9. Interventions: EBV-specific cytotoxic T-lymphocytes (Drug), biological response modifier therapy (Procedure), leukocyte therapy (Procedure), peripheral… to EBV-specific cytotoxic T-lymphocytes (Drug), biological therapy (Procedure), leukocyte therapy (Procedure), peripheral blood lymphocyte…v4
  10. Study sites revised (12)v3
  11. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00033475
Lead Sponsor University of Edinburgh
Conditions
(from sponsor)		 Lymphoproliferative Disorder
Related terms Lymphoproliferative Disorders
Enrollment 50 participants
Start Date
Updated on ClinicalTrials.gov