αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

Launched by NATIONWIDE CHILDREN'S HOSPITAL · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach for children and young adults with blood cancers who need a stem cell transplant but don't have a matched sibling donor. The researchers are using a special device to remove certain types of cells from the donor's stem cells before the transplant. This process aims to make the transplant safer and more effective. Participants will receive stem cells from a matched unrelated donor or a mismatched donor, along with medications that help the body accept the new cells.

To be eligible for this trial, patients need to be 30 years old or younger and have a type of blood cancer that can be treated with a transplant. They must also have good overall health, meaning their organs are functioning well, and they should not have a suitable donor available. During the trial, participants will undergo a series of evaluations and treatments, and they or their guardians will need to provide consent to join. Overall, this trial is focused on finding better options for young patients facing serious health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≤ 30 years
• • Patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor.
• • Karnofsky Index or Lansky Performance Scale ≥ 60 % on pre-transplant evaluation.
• • Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients ≤ 16 years of age.
• • Patient or legal guardian must give informed consent if patient is ≥ 18 years. Legal guardian must give informed consent (and patient must give assent if appropriate) if patient is \< 18 years.
• • Adequate organ function (within 4 weeks of initiation of preparative regimen). For patients receiving Myeloablative conditioning (MAC) on this platform, they should meet organ function to tolerate MAC. Similar if patients are receiving Reduced intensity conditioning (RIC).
• • High resolution human leukocyte antigen (HLA) available
• Exclusion Criteria:
• • Patient does not have a suitable donor who is willing and able (meets donor criteria).
• • Patient reports a history of allergic reactions to murine protein
• • Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. Female patients of childbearing potential females ≥11 years of age or post- menarche and should have a negative pregnancy test
• • Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation. Viremia by Pluripotency Check (PCR) analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic -
• • Patients receiving umbilical cord blood and matched sibling donor transplants