RECRUITING

Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT

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Conditions

LeukemiaHigh Risk Acute Lymphoblastic LeukemiaHigh Risk Acute Myeloid LeukemiaRelapse LeukemiaMDS (Myelodysplastic Syndrome)Relapsed Non-Hodgkin LymphomaAcquired Aplastic AnemiaInherited BMF SyndromeImmunodeficiencyPrimary Immune Regulatory DisorderHemoglobinopathiesBone Marrow FailureInborn Errors of MetabolismHLHalpha beta T cell depletionCD45RACD45ROGVHD preventionMemory T cells

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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 (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.

Official Title

Phase 1/2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab/CD19 Depleted Hematopoietic Stem Cell Transplant

Quick Facts

Study Start:2025-03-21
Study Completion:2032-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06839456

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:1 Month to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Disease for which allogeneic HSCT may be curative.
  2. 2. Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS).
  3. 3. Patients must be 25 years of age and less
  4. 4. Evaluation for organ and infectious status as per our CTTS standard operating procedure.
  5. 5. Signed consent by parent/guardian or able to give consent if 18 years of age and older.
  6. 6. Participants of childbearing potential must have a negative pregnancy test as per institutional SOP.
  1. 1. Patients who have performance score less than 60.
  2. 2. No suitable donor available for mobilized peripheral stem cells.
  3. 3. Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.
  4. 4. Planned receipt of alemtuzumab during conditioning.
  5. 5. Patients with an available 10/10 HLA matched sibling donor.
  6. 6. Patients who do not meet institutional disease, organ or infectious criteria.
  7. 1. Unrelated donor meets National Marrow Donor Program criteria for donation.
  8. 2. Related donor (at least haploidentical) willing and able to donate mobilized peripheral stem cells.
  9. 3. HLA testing/matching
  10. * HLA testing to be done by molecular methods for A, B, C, DRB1, DQB1
  11. * Related donor: Must be ≥ 5/10 match
  12. * Unrelated donor: 10/10 or 9/10 match
  13. * KIR typing for haploidentical donor for hematologic malignancies
  14. * Donor specific HLA antibodies (DSA) should be assessed for all subjects receiving an HLA mismatched graft (≤ 9/10).
  15. 4. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection
  16. 5. Donors must be willing to sign consent to participate in this study.

Contacts and Locations

Study Contact

Megan Atkinson
CONTACT
215-590-2820
cttsbmtintake@chop.edu
Linda Zitkus, BSN,RN
CONTACT
zitkusl@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 Date2025-03-21
Study Completion Date2032-03

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2032-03

Terms related to this study

Keywords Provided by Researchers

  • alpha beta T cell depletion
  • CD45RA
  • CD45RO
  • GVHD prevention
  • Memory T cells

Additional Relevant MeSH Terms

  • Leukemia
  • High Risk Acute Lymphoblastic Leukemia
  • High Risk Acute Myeloid Leukemia
  • Relapse Leukemia
  • MDS (Myelodysplastic Syndrome)
  • Relapsed Non-Hodgkin Lymphoma
  • Acquired Aplastic Anemia
  • Inherited BMF Syndrome
  • Immunodeficiency
  • Primary Immune Regulatory Disorder
  • Hemoglobinopathies
  • Bone Marrow Failure
  • Inborn Errors of Metabolism
  • HLH