Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells (PBSC)

Phase 2

Completed

• Conditions: Hematologic Malignancies
• Interventions: Procedure: Unmanipulated PBSC after nonmyeloablative conditioning; Procedure: CD8-depleted PBSC after nonmyeloablative conditioning

• Registration Number: NCT00693927
• Lead Sponsor: University of Liege

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2005-05
• Study Completion: 2008-05
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Unmanipulated PBSC after nonmyeloablative conditioning	Unmanipulated PBSC
2	CD8-depleted PBSC after nonmyeloablative conditioning	CD8-Depleted PBSC

Primary Outcome Measures

Name	Time	Method
Incidence of acute GVHD in CD8-depleted versus unmanipulated groups	180 days
Incidence of chronic GVHD (overall and extensive) in CD8-depleted versus unmanipulated groups.	1-year

Secondary Outcome Measures

Name	Time	Method
Incidence of graft rejection [according to the risk of transplant rejection (see table 1 above)] in CD8-depleted versus unmanipulated groups.	1-year
T cell (CD3) and myeloid (CD13) chimerism in CD8-depleted versus unmanipulated groups.	1-year and then long term
Quality and timing of immune reconstitution in CD8-depleted versus unmanipulated groups.	1-year

Trial Locations

Locations (1)

CHU Sart Tilman; 🇧🇪 Liege, Belgium