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

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jan 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients, particularly children and young adults under 25 years old, who have certain types of blood cancers like leukemia and lymphoma and are at high risk for infections after a bone marrow transplant. The goal of the study is to see if adding a specific type of immune cell, known as CD45RA depleted cells, back into the patient's system can help boost their immune response and reduce the chances of developing serious infections, which can occur after the transplant.

To participate in this trial, patients must be undergoing their first bone marrow transplant and have specific types of acute leukemia or other hematologic cancers. Parents or guardians will need to provide consent for those under 18, while patients over 18 can give consent themselves. The trial is currently recruiting participants, and those who join can expect close monitoring and support to help manage their health during this important treatment process. It's also important to note that this trial has specific eligibility requirements regarding organ function and the availability of suitable donors for the stem cells needed for the transplant.

Gender

ALL

Eligibility criteria

• 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
• • 5. Pregnant Participants
• • 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