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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Megan Atkinson
cttsbmtintake@chop.edu
215-590-2820
Backup
Patricia Hankins, BSN, RN, CCRC
hankinsp@chop.edu
215-590-5168
Time Frame
Start Date: 2019-03-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 50
Treatments
Other: TBI regimen
Standard of care myeloablative regimens will be used based on disease type and clinical status at time of transplant. Patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma will receive total body irradiation (TBI) regimen (thiotepa, cyclophosphamide, TBI).
Other: TBI or busulfan regimen
Standard of care myeloablative regimens will be used based on disease type and clinical status at time of transplant. Patients not diagnosed with ALL or lymphoblastic lymphoma may receive either total body irradiation (TBI) regimen (thiotepa, cyclophosphamide, TBI) or busulfan containing regimen (thiotepa, cyclophosphamide, busulfan).
Authors
Tim Olson, Nancy Bunin
Sponsors
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov