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

NCT ID: NCT00693927

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2008-05-31

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.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Unmanipulated PBSC

Group Type: ACTIVE_COMPARATOR

Unmanipulated PBSC after nonmyeloablative conditioning

Intervention Type: PROCEDURE

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

CD8-Depleted PBSC

Group Type: EXPERIMENTAL

CD8-depleted PBSC after nonmyeloablative conditioning

Intervention Type: PROCEDURE

Interventions

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

Intervention Type: PROCEDURE

CD8-depleted PBSC after nonmyeloablative conditioning

Intervention Type: PROCEDURE

Other Intervention 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

Eligibility Criteria

Inclusion Criteria

• Male or female; female patients must use a reliable contraception method;
• Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
• HIV negative;
• No terminal organ failure;
• No uncontrolled infection, arrhythmia or hypertension;
• Family donor (HLA-identical) or unrelated donor (matched for A-B by low resolution typing and for DRB1-DQB1 by high resolution typing);
• No previous radiation therapy precluding the use of 2 Gy TBI
• Informed consent given by patient or his/her guardian if of minor age.

1.3. Clinical situations

• Theoretical disease indication for a standard allo-transplant, but not feasible because:
• Age > 55 yrs;
• Unacceptable end organ performance;
• Patient's refusal.
• Indication for a standard auto-transplant:

• perform mini-allotransplantation 2-6 months after standard autotransplant.
• Not an indication for intensification but a potential candidate for cellular immunotherapy.

2. Donors

• Related to the recipient (sibling, parent or child) or unrelated;
• Male or female;
• Weight > 15 Kg (because of leukapheresis);
• HIV negative;
• No major contraindication for allogeneic PBSC donation by generally accepted criteria;
• Informed consent given by donor or his/her guardian if of minor age.

• Unable to undergo leukapheresis because of poor vein access or other reasons.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Yves Beguin

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yves Beguin, MD, PhD

Role: STUDY_CHAIR

University of Liege

Locations

CHU Sart Tilman

Liège, Liege, Belgium

Countries

Belgium

Other Identifiers

Minitransplant - random

Identifier Type: -

Identifier Source: org_study_id