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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

URL:

https://clinicaltrials.gov/show/NCT02158767

Trial Eligibility

Document

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

  • ORG STUDY ID: CASE16Z13
  • NCT ID: NCT02158767

Conditions

  • Hematopoietic/Lymphoid Cancer

Interventions

DrugSynonymsArms
Allogenic T cell-depleted hematopoietic stem cell transplantation

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

NameTypeDescriptionInterventions

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
Maximum Eligible Age:80 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Details

Phase:
Primary Purpose:Expanded Access
Overall Status:Available
Lead Sponsor:Leland Metheny

Last Updated

June 28, 2021