CHU Sart Tilman
Liège, Liege, B4000, Belgium
NCT Number: 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.
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Notify MeUp to 70 year
All sexes
Interventional
Phase 2
Liège, Liege, B4000, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
1.1. Diseases
Malignant diseases confirmed histologically and not rapidly progressing:
1.2. Inclusion criteria
1.3. Clinical situations
2.1. Inclusion criteria
2.2. Exclusion criteria
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
Other names: Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2)., CD8-depleted PBSC from HLA-identical sibling or HLA-matched related or unrelated donor
Time frame: 180 days
Time frame: 1-year
Time frame: 1-year
Time frame: 1-year and then long term
Time frame: 1-year
University of Liege
Other
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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