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Completed

NCT Number: NCT00693927

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patients

1.1. Diseases

Malignant diseases confirmed histologically and not rapidly progressing:

  • Hematologic malignancies
  • AML;
  • ALL;
  • CML and other myeloproliferative disorders;
  • MDS;
  • Multiple myeloma;
  • CLL;
  • Non-Hodgkin's lymphoma;
  • Hodgkin's disease.
  • Non-hematologic malignancies
  • Renal cell carcinoma (metastatic).

1.2. 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.
  • Donors

2.1. Inclusion criteria

  • 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.

2.2. Exclusion criteria

  • Any condition not fulfilling inclusion criteria;
  • Unable to undergo leukapheresis because of poor vein access or other reasons.

Treatment and study plan

Unmanipulated PBSC after nonmyeloablative conditioning

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

CD8-depleted PBSC after nonmyeloablative conditioning

Procedure

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

Primary outcomes

  1. Incidence of acute GVHD in CD8-depleted versus unmanipulated groups

    Time frame: 180 days

  2. Incidence of chronic GVHD (overall and extensive) in CD8-depleted versus unmanipulated groups.

    Time frame: 1-year

Secondary outcomes

  1. Incidence of graft rejection [according to the risk of transplant rejection (see table 1 above)] in CD8-depleted versus unmanipulated groups.

    Time frame: 1-year

  2. T cell (CD3) and myeloid (CD13) chimerism in CD8-depleted versus unmanipulated groups.

    Time frame: 1-year and then long term

  3. Quality and timing of immune reconstitution in CD8-depleted versus unmanipulated groups.

    Time frame: 1-year

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial

Important dates

Study start
2002
Primary completion
2005
Study completion
2008
First posted
Jun 9, 2008
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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