Depletion of specific immune cells for stem cell transplantation in young patients
αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT) for Children and Young Adults With Hematologic Malignancies
This study is testing a new way to prepare stem cells for children and young adults with blood cancers by removing certain immune cells to see if it helps them have a safer and more effective transplant from unrelated donors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06082947 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a specialized device, CliniMACS®, to deplete αβT cells and CD19+ B cells in children and young adults with hematologic malignancies who require an alternative donor for allogeneic hematopoietic stem cell transplantation (HSCT). Participants will receive stem cells from matched unrelated, mismatched unrelated, or haploidentical donors after undergoing mobilization with granulocyte-colony stimulating factor (G-CSF) and possibly Plerixafor. The study aims to optimize the graft composition based on the transplant indication and assess the safety and efficacy of this approach.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 30 years or younger with hematologic malignancies who lack a suitable matched sibling donor.
Not a fit: Patients who have a suitable matched donor or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve transplant outcomes and reduce complications for young patients with hematologic malignancies.
How similar studies have performed: While similar approaches have been explored, this specific method of αβT cell and CD19+ B cell depletion in the context of HSCT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Clelie Peck
- Email: clelie.peck@nationwidechildrens.org
- Phone: 614-722-5634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.