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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2024
  • participants needed
    30
  • sponsor
    Children's Hospital of Philadelphia
Updated on 10 April 2022
cancer
stem cell transplantation
graft versus host disease
myeloid leukemia
lymphoid leukemia
hematologic malignancy
bone marrow transplant
myelodysplastic syndromes
acute leukemia
residual disease
leukemia
bone marrow procedure
lymphocytic leukemia
minimal residual disease
residual tumor
graft-versus-host disease
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.

Description

The risk of severe graft versus host disease (GVHD) is increased with the use of unrelated and partially matched related donors. T cell depletion reduces the risk of severe GVHD, but immune reconstitution is delayed. Important memory T cells that may protect patients from fungal and viral infections are also removed in the T depletion process. CD45RA depletion has been studied both as a single step to reduce the risk of GVHD, and also, in conjunction with αβTCR depleted hematopoietic stem cell grafts to accelerate immune reconstitution. This is a single institutional pilot trial of this T cell depletion technique. Patients with acute leukemias at high risk for relapse are eligible to participate. Patients will be given CD45RA depleted donor peripheral stem cells (PSCs) following T depleted hematopoietic stem cell transplant (HSCT). A short course of GVHD prophylaxis will be used after CD45RA depletion.

Details
Condition Acute Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Mixed Lineage Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma, Juvenile Myelomonocytic Leukemia
Treatment CliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback
Clinical Study IdentifierNCT03810196
SponsorChildren's Hospital of Philadelphia
Last Modified on10 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: Patients <25 years
First allogeneic HSCT only
Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia
Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP)
Signed consent by parent/guardian or able to give consent if >18 years

Exclusion Criteria

Patients who do not meet institutional disease, organ or infectious criteria
No suitable donor available for mobilized peripheral stem cells
Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects
Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma
Donor selection and eligibility
Unrelated donor meets National Marrow Donor Program criteria for donation
HLA testing/matching
Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection
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