RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-03-01
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03810196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age: Patients \<25 years.
  2. 2. First allogeneic HSCT only.
  3. 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. 4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).
  5. 5. Signed consent by parent/guardian or able to give consent if \>18 years.
  1. 1. Patients who do not meet institutional disease, organ or infectious criteria
  2. 2. No suitable donor available for mobilized peripheral stem cells
  3. 3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.
  4. 4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma
  5. 1. Unrelated donor meets National Marrow Donor Program criteria for donation
  6. 2. HLA testing/matching
  7. 3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection

Contacts and Locations

Study Contact

Megan Atkinson
CONTACT
215-590-2820
cttsbmtintake@chop.edu
Patricia Hankins, BSN, RN, CCRC
CONTACT
215-590-5168
hankinsp@chop.edu

Principal Investigator

Timothy Olson, MD, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Timothy Olson, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-01
Study Completion Date2026-01

Study Record Updates

Study Start Date2019-03-01
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

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