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NCT Number: NCT06082947

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

This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT). Patients will receive an allogenic HSCT from a matched unrelated donor (MUD), mismatch unrelated donor (MMUD) or a mismatched related (haploidentical) donor. Patients will receive a granulocyte-colony stimulating factor (G-CSF) ± Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS® αβT cell/CD19+B cell depletion. Cluster of Differentiation 34 (CD34) and αβT cell content of the graft is determined based on the transplant indication.

Recruiting

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Key information

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

Hemalatha Rangarajan, MD

CONTACT

[email protected]

Rolla Abu-Arja, MD

CONTACT

[email protected]

614-722-3250

Rolla Abu-Arja, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CliniMACS®

Device

CliniMACS® αβT cell/CD19+B cell depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

Primary outcomes

  1. 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)

    Time frame: 1 year

    One-year overall survival of patients undergoing allogeneic HSCT

Secondary outcomes

  1. Neutrophil and platelet engraftment following TCR αβ/CD19+ depleted alternative donor (MUD, MMUD and haploidentical) HSCT

    Time frame: 100 days

    Neutrophil and platelet engraftment by day 100

  2. Incidence of final status graft failure

    Time frame: 1 year

    Incidence of final status graft failure by 1 year

  3. Incidence grade III-IV acute graft versus host disease (GVHD)

    Time frame: 1 year

    Incidence grade III-IV acute graft versus host disease (GVHD) by 1 year

  4. Incidence of chronic GVHD

    Time frame: 1 year

    Incidence of chronic GVHD by 1 year

  5. 100 day and 1 year Transplant related mortality

    Time frame: 1 year

    100 day and 1 year Transplant related mortality by 1 year

  6. 1 year Event free survival

    Time frame: 1 year

    1 year Event free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Clelie Peck

CONTACT

[email protected]

614-722-5634

Lauren Rayman

CONTACT

[email protected]

614-722-3729

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT) for Children and Young Adults With Hematologic Malignancies

Acronym: TB19DHCT

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Oct 13, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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