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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 25
SponsorChildren's Hospital of Philadelphia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: TBI regimenOther 1 intervention
Group B: TBI or busulfan regimenOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of acute graft vs. host disease (GVHD)

Incidence of acute graft vs. host disease (GVHD) (reaction of donor immune cells against host tissues)

Time frame
Up to 100 days post-transplantation

Secondary outcomes

Other outcomes

Sponsors and contacts

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