TCR +/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders

  • STATUS
    Recruiting
  • End date
    Sep 26, 2025
  • participants needed
    80
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 26 January 2021

Summary

The purpose of this study is to investigate the safety and efficacy of TCR+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS immunomagnetic selection device (Miltenyi Biotec).

Description

Acute graft versus host disease (GVHD) remains a significant cause of morbidity and mortality and is the biggest barrier to successful allogeneic hematopoietic cell transplantation (HSCT) outcomes. Improved methods of acute GVHD prevention are needed. TCR+/CD19+ depletion of allogeneic hematopoietic stem cell products offers an opportunity to limit the risk of acute GVHD by removing TCR+ T cells and CD19+ B cells which participate in acute GVHD initiation and perpetuation. The purpose of this study is to investigate the safety and efficacy of TCR+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS immunomagnetic selection device (Miltenyi Biotec).

Details
Condition Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Hematopoietic Cell Transplantation
Treatment TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)
Clinical Study IdentifierNCT04088760
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have Allogeneic Hematopoietic Cell Transplantation?
Do you have any of these conditions: Allogeneic Hematopoietic Cell Transplantation or Allogeneic Hematopoietic Stem Cell Transplantation?
Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic HSCT who lacks an HLA-genotypically matched related donor. Genotypically matched related donors are allowed when there is a clinical desire to avoid the use of GVHD prophylaxis medications

Exclusion Criteria

Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening infection. Patients with a prior history of allogenic transplant without active GVHD or life-threatening infection can be considered
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