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αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT) (TB19DHCT)

Primary Purpose

Hematopoietic Stem Cell Transplantation, Hematologic Malignancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CliniMACS®
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematopoietic Stem Cell Transplantation

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HSCT using TCR αβ/CD19+ depleted grafts

    Arm Description

    Allogeneic HSCT using the TCR αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)

    Outcomes

    Primary Outcome 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)
    One-year overall survival of patients undergoing allogeneic HSCT

    Secondary Outcome Measures

    Neutrophil and platelet engraftment following TCR αβ/CD19+ depleted alternative donor (MUD, MMUD and haploidentical) HSCT
    Neutrophil and platelet engraftment by day 100
    Incidence of final status graft failure
    Incidence of final status graft failure by 1 year
    Incidence grade III-IV acute graft versus host disease (GVHD)
    Incidence grade III-IV acute graft versus host disease (GVHD) by 1 year
    Incidence of chronic GVHD
    Incidence of chronic GVHD by 1 year
    100 day and 1 year Transplant related mortality
    100 day and 1 year Transplant related mortality by 1 year
    1 year Event free survival
    1 year Event free survival

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Nationwide Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06082947
    Brief Title
    αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)
    Acronym
    TB19DHCT
    Official Title
    αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT) for Children and Young Adults With Hematologic Malignancies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2028 (Anticipated)
    Study Completion Date
    December 1, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nationwide Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematopoietic Stem Cell Transplantation, Hematologic Malignancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HSCT using TCR αβ/CD19+ depleted grafts
    Arm Type
    Experimental
    Arm Description
    Allogeneic HSCT using the TCR αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)
    Intervention Type
    Device
    Intervention Name(s)
    CliniMACS®
    Intervention Description
    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 Outcome Measure Information:
    Title
    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)
    Description
    One-year overall survival of patients undergoing allogeneic HSCT
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Neutrophil and platelet engraftment following TCR αβ/CD19+ depleted alternative donor (MUD, MMUD and haploidentical) HSCT
    Description
    Neutrophil and platelet engraftment by day 100
    Time Frame
    100 days
    Title
    Incidence of final status graft failure
    Description
    Incidence of final status graft failure by 1 year
    Time Frame
    1 year
    Title
    Incidence grade III-IV acute graft versus host disease (GVHD)
    Description
    Incidence grade III-IV acute graft versus host disease (GVHD) by 1 year
    Time Frame
    1 year
    Title
    Incidence of chronic GVHD
    Description
    Incidence of chronic GVHD by 1 year
    Time Frame
    1 year
    Title
    100 day and 1 year Transplant related mortality
    Description
    100 day and 1 year Transplant related mortality by 1 year
    Time Frame
    1 year
    Title
    1 year Event free survival
    Description
    1 year Event free survival
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clelie Peck
    Phone
    614-722-5634
    Email
    clelie.peck@nationwidechildrens.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lauren Rayman
    Phone
    614-722-3729
    Email
    lauren.rayman@nationwidechildrens.org

    12. IPD Sharing Statement

    Learn more about this trial

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

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