RecruitingNot ApplicableNCT03810196

CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT

CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ/CD19 Depleted Hematopoietic Stem Cell Transplant

Sponsor

Children's Hospital of Philadelphia

Enrollment

50 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Acute Leukemia Myelodysplastic Syndromes Mixed Lineage Leukemia Lymphoblastic Lymphoma Burkitt Lymphoma Juvenile Myelomonocytic Leukemia

Summary

The major morbidities of allogeneic hematopoietic stem cell transplant with non-human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life threatening infections. T depletion of the donor hematopoietic stem cell graft is effective in preventing GVHD, but immune reconstitution is slow, increasing the risk of infections. An addback of donor CD45RA (naive T cells) depleted cells may improve immune reconstitution and help decrease the risk of infections.

Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving additional immune cells (called CD45RA-depleted peripheral stem cells — a specific type of blood stem cells with key immune-fighting cells removed to reduce the risk of attacking the patient's own body) can help children and young adults fight serious viral or fungal infections after a bone marrow transplant. **You may be eligible if...** - You are under 25 years old - You are receiving your first bone marrow (stem cell) transplant - You have a high-risk blood cancer such as leukemia (including AML, ALL, MDS, or related conditions) - A parent, guardian, or you yourself (if 18+) has given written consent **You may NOT be eligible if...** - You do not meet the hospital's criteria for disease, organ function, or infection status - A suitable stem cell donor is not available - You have already had a bone marrow transplant before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback

Peripheral stem cell (PSC) product will be processed using the CliniMACS device for TCRαβ and T cell depletion. Approximately 10% of the PSCs will undergo CD45RA depletion and cryopreservation. Patients will receive CD45RA depleted infusion after the TCRab PSCT.

Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT03810196

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