Naive T-cell depletion in stem cell transplantation.
Marie Bleakley
https://pubmed.ncbi.nlm.nih.gov/33049057Actively Recruiting
Phase 2
Age: 6Months - 26Years
All Genders
Healthy Volunteers
ID03779854
Phase II Randomized Trial of Naive T Cell Depletion to Prevent Chronic Graft-Versus-Host Disease in Children and Young Adults with Blood Cancers Undergoing Donor Stem Cell Transplant
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-14
68
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of naive T-cell depletion to prevent chronic graft-versus-host disease (GVHD) in children and young adults with blood cancers undergoing donor stem cell transplant. This phase II trial focuses on patients with various acute leukemias and related blood conditions. The study aims to determine if removing naive T cells from donor cells before transplant can reduce the risk of donor immune cells attacking the patient's healthy tissues. Participants are randomly assigned to one of two groups. One group receives a transplant of naive T-cell depleted peripheral blood stem cells, while the other receives unmanipulated T cell-replete bone marrow. Before transplant, all patients undergo one of three conditioning regimens involving combinations of total body irradiation and chemotherapy drugs such as thiotepa, fludarabine, cyclophosphamide, and busulfan. After transplant, all receive graft-versus-host disease prevention treatment with tacrolimus and methotrexate. During the study, patients have echocardiograms and cerebrospinal fluid collected at the start, along with blood samples and bone marrow tests throughout. Follow-up visits occur frequently up to two years to monitor health and disease status. Researchers measure success by neutrophil engraftment, feasibility of the treatment, and survival without GVHD or relapse at one year. Safety and long-term outcomes are also tracked over 24 months.
CONDITIONS
Brief Title
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
Who Can Participate
Age: 6Months - 26Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosis of specific blood cancers such as acute lymphoblastic leukemia with less than 5% marrow blasts, acute myeloid leukemia with less than 25% marrow blasts, or related neoplasms.
- Age between 6 months and 26 years at consent.
- Matched related or unrelated donor available with 8/8 HLA match.
- Planned stem cell product is peripheral blood stem cells or bone marrow.
- Karnofsky or Lansky performance score of 60% or higher.
- Left ventricular ejection fraction at rest 40% or higher.
- Lung function with DLCO 60% or higher or oxygen saturation 92% or higher if unable to perform lung tests.
- Total bilirubin, ALT, and AST levels not more than twice the upper limit of normal unless related to disease or medication.
- Normal serum creatinine for age or creatinine clearance above 40 mL/min/1.73m2.
- Informed consent or legal guardian permission obtained.
- Donors must be 14 years or older, matched at 8/8 HLA alleles, and able to donate in the USA.
- Donors must meet specific infection and eligibility criteria based on related or unrelated status.
You will not qualify if you...
- Active central nervous system disease unless cleared by evaluation before conditioning.
- Participation in other experimental GVHD prevention protocols.
- Body weight over 100 kg for matched related donors or over 75 kg for matched unrelated donors without protocol PI approval.
- HIV positive status.
- Uncontrolled infections excluding upper respiratory tract infections.
- Life expectancy less than 3 months due to causes other than acute leukemia or myelodysplastic syndrome.
- Significant medical conditions making transplant unsuitable.
- Previous allogeneic or autologous stem cell transplant.
- Pregnancy or breastfeeding.
- Females of childbearing potential unwilling to use effective birth control during and up to 12 months after transplant.
- Known allergy to tacrolimus, fludarabine, or methotrexate.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Conditioning Regimen
Duration - Approximately 7 to 14 days
Participants undergo one of three chemotherapy and radiation conditioning regimens before transplant.
Daily visits for up to 14 days
Transplant
Duration - 1 day
Participants receive either naive T-cell depleted peripheral blood stem cells or unmanipulated T cell-replete bone marrow on day 0.
1 visit (in-person) on transplant day
GVHD Prophylaxis
Duration - Approximately 50 days with tapering after
Participants receive immunosuppressive medications including tacrolimus and methotrexate to prevent graft-versus-host disease.
Multiple visits between day -1 and day 50
Follow-up
Duration - Up to 2 years
Participants are monitored after treatment completion for safety, effectiveness, and long-term outcomes including graft-versus-host disease and survival.
Visits at days 28, 56, 90, 180, 270, 365, and months 15, 18, 21, and 24
Trial Site Locations
Total: 10 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 200100
Withdrawn
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
4
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Dana Farber / Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
6
UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center)
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
7
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
9
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
10
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
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Research Team
M
Marie Bleakley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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