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CliniMACS® for Blood Cancers in Children and Young Adults

This study is for children and young adults up to 30 years old with blood cancers (hematologic malignancies) who need a stem cell transplant but don't have a matched sibling donor. It's testing a special device called CliniMACS® that prepares donor stem cells for transplant. The goal is to see how many patients are still alive one year after receiving this type of transplant from an alternative donor (like an unrelated donor or a partially matched family member). This study is currently recruiting 50 participants.

Study design
This is an interventional study planning to enroll 50 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for one year to measure overall survival after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06082947

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

Recruiting
NAUp to 30InterventionalTreatment
Nationwide Children's Hospital
~50 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:CliniMACS®

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
One-year overall survival of patients undergoing allogeneic HSCT using the T-Cell Receptor (TCR) αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)
Measured over 1 year

Conditions

Hematopoietic Stem Cell Transplantation
Hematologic Malignancy

Explore related trials

Malignant neoplasm of lymphoid, hematopoietic and/or related tissue

NCT06082947

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nationwide Children's Hospital

    Columbus, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Clelie Peck
[email protected]
614-722-5634
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • One-year overall survival of patients undergoing allogeneic HSCT using the T-Cell Receptor (TCR) αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)1 year

    One-year overall survival of patients undergoing allogeneic HSCT