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Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.

NCT02158767

Description:

This clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant. Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").

Recruiting Status:

Available

Trial Eligibility

Document

Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic <span class="go-doc-concept go-doc-intervention">Stem Cell</span> Grafts.

Title

  • Brief Title: Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
  • Official Title: Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
  • Clinical Trial IDs

    NCT ID: NCT02158767

    ORG ID: CASE16Z13

    NCI ID: NCI-2013-02383

    Trial Conditions

    Hematopoietic/Lymphoid Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This clinical trial studies the use of a second infusion of donor hematopoietic cells that
    have had removal of T cells for the treatment of engraftment failure after a first
    hematopoietic stem cell transplant.

    Hematopoietic cell transplants from donors can be complicated by complete or incomplete
    failure of recovery of blood counts. This results in frequent needs for transfusions and
    other methods to maintain blood counts at acceptable levels. One way of improving the blood
    counts in the recipient is to give a "booster" dose of cells from the donor, but this is
    associated with increased risk of an immune reaction from the donor cells against the
    recipient cells. To decrease this risk, it is possible to decrease the amount of T cells,
    responsible for this type of immune reaction. These cells are removed by a special handling
    of the graft, which allows to remove the cells directly or indirectly (by selecting other
    cells to "stay" in the graft").

    Detailed Description

    PRIMARY OBJECTIVES:

    I. To provide patients with suboptimal engraftment after allogeneic stem cell
    transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or
    T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.

    OUTLINE:

    Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion
    (PBSCT) over 1-3 hours.

    After completion of study treatment, patients are followed up for 100 days.

    Trial Arms

    Name Type Description Interventions

    Eligibility Criteria

    Inclusion Criteria:

    - Patients who received a prior hematopoietic progenitor cell transplantation,
    including matched sibling and unrelated donor transplants, mismatched sibling and
    unrelated donor transplants and haploidentical transplants from related donors

    - Patients with a presence of secondary engraftment failure defined as decrease in
    donor chimerism by >= 50% (i.e. 40% to 20%) in two measurements done at least 30 days
    apart

    - OR a presence of incomplete graft function manifested by presence of persistent or
    new cytopenias 60 or more days after transplantation:

    - Anemia; hemoglobin less than 8g/dL, or red blood cell transfusion requirements
    over the preceding 4 weeks

    - Neutropenia, with absolute neutrophil count less than 1,000 neutrophils per
    microliter or requirement of growth factor support over the preceding 4 weeks

    - Thrombocytopenia, with platelet counts below 20,000 platelets per microliter or
    platelet transfusion requirements over the preceding 4 weeks

    Exclusion Criteria:

    - Patients for whom hematopoietic progenitor cells from the original donor are not
    available

    - Presence of reversible causes of engraftment failure or incomplete graft function,
    including

    - Active viral infection

    - Medications

    - Acute or chronic graft versus host disease (GVHD) that is not controlled to less
    or equal than stage II with immunosuppressants

    Minimum Eligible Age: N/A

    Maximum Eligible Age: 80 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Secondary Outcome Measures

    Trial Keywords