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Sponsored by: |
University Hospital of Liege |
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Information provided by: | University Hospital of Liege |
ClinicalTrials.gov Identifier: | NCT00693927 |
Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.
Condition | Intervention | Phase |
---|---|---|
Hematologic Malignancies |
Procedure: Unmanipulated PBSC after nonmyeloablative conditioning Procedure: CD8-depleted PBSC after nonmyeloablative conditioning |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Nonmyeloablative Stem Cell Transplantation With CD8-Depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial |
Enrollment: | 54 |
Study Start Date: | March 2002 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Unmanipulated PBSC
|
Procedure: Unmanipulated PBSC after nonmyeloablative conditioning
Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2). Unmanipulated PBSC from HLA-identical sibling or HLA-matched related or unrelated donor |
2: Experimental
CD8-Depleted PBSC
|
Procedure: CD8-depleted PBSC after nonmyeloablative conditioning |
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients
1.1. Diseases
Malignant diseases confirmed histologically and not rapidly progressing:
Hematologic malignancies
Non-hematologic malignancies
1.2. Inclusion criteria
1.3. Clinical situations
Indication for a standard auto-transplant:
2.1. Inclusion criteria
2.2. Exclusion criteria
Responsible Party: | University Hospital of Liege ( Yves Beguin ) |
Study ID Numbers: | Minitransplant - random |
Study First Received: | May 29, 2008 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00693927 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Hematopoietic cell transplantation Allogeneic Nonmyeloablative CD8-depletion |
PBSC GVHD Hematological malignancies and renal cell carcinoma |
Kidney Cancer Renal Cancer Hematologic Neoplasms Hematologic Diseases |
Carcinoma, Renal Cell Fludarabine Fludarabine monophosphate Carcinoma |
Neoplasms Neoplasms by Site Hematologic Neoplasms Hematologic Diseases |