TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of TCRαβ+/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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed 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. TCRαβ+/CD19+ depletion of allogeneic hematopoietic stem cell products offers an opportunity to limit the risk of acute GVHD by removing TCRαβ+ 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 TCRαβ+/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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TCRαβ+/CD19+ depleted HSCT
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Drug: TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)
The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold.
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Outcome Measures
Primary Outcome Measures
- Incidence of infusion-related reactions [100 days]
Secondary Outcome Measures
- Engraftment and Sustained Donor Chimerism [100 days and 1 year]
- Incidence of acute GVHD [100 days]
- Incidence of chronic GVHD [1 year]
- GVHD-free survival [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-8568