Depletion of specific immune cells for stem cell transplantation in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Clelie Peck
• Email: clelie.peck@nationwidechildrens.org
• Phone: 614-722-5634

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personalized ATG dosing in unrelated donor stem cell transplants

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.