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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810196
• Other study ID #: 18-015286
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital of Philadelphia
• Contact: Patricia Hankins, BSN, RN, CCRC
• Phone: 215-590-5168
• Email: hankinsp[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

Inclusion Criteria:

1. Age: Patients <25 years.

2. First allogeneic HSCT only.

3. 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

4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).

5. Signed consent by parent/guardian or able to give consent if >18 years.

Exclusion Criteria:

1. Patients who do not meet institutional disease, organ or infectious criteria

2. No suitable donor available for mobilized peripheral stem cells

3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.

4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma Donor selection and eligibility

1. Unrelated donor meets National Marrow Donor Program criteria for donation

2. HLA testing/matching

3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection

Related Conditions & MeSH terms

• Acute Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Burkitt Lymphoma
• Juvenile Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelomonocytic, Juvenile
• Lymphoblastic Lymphoma
• Lymphoma
• Mixed Lineage Leukemia
• Mycoses
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Device:
• CliniMACS Cell Processing System for TCRaß + T Cell and CD45RA Depleted Peripheral Stem Cell Addback
Peripheral stem cell (PSC) product will be processed using the CliniMACS device for TCRaß 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

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute graft vs. host disease (GVHD)	Incidence of acute graft vs. host disease (GVHD) (reaction of donor immune cells against host tissues)	Up to 100 days post-transplantation