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Trial Title:
αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)
NCT ID:
NCT06082947
Condition:
Hematopoietic Stem Cell Transplantation
Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
CliniMACS®
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)
Arm group label:
HSCT using TCR αβ/CD19+ depleted grafts
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
30 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nationwide Children's Hospital
Address:
City:
Columbus
Zip:
43205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rolla Abu-Arja, MD
Phone:
614-722-3250
Email:
rolla.abu-arja@nationwidechildrens.org
Contact backup:
Last name:
Hemalatha Rangarajan, MD
Email:
hemalatha.rangarajan@nationwidechildrens.org
Investigator:
Last name:
Rolla Abu-Arja, MD
Email:
Principal Investigator
Start date:
December 18, 2023
Completion date:
December 1, 2030
Lead sponsor:
Agency:
Nationwide Children's Hospital
Agency class:
Other
Source:
Nationwide Children's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082947
