Actively Recruiting
Naive T Cell Depletion for Preventing 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
487 weeks
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
This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Age 6 months to 26 years at the time of consent
- Diagnosis of acute lymphoblastic leukemia with less than 5% marrow blasts
- Diagnosis of acute myeloid leukemia with less than 25% marrow blasts
- Diagnosis of other acute leukemia or related neoplasm with less than 5% marrow blasts
- Diagnosis of myelodysplastic syndrome with excess blasts and prior cytotoxic induction chemotherapy
- Candidate for allogeneic hematopoietic cell transplantation as determined by study investigator
- Planned donor is a matched related or unrelated donor 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 of at least 40%
- Lung function with DLCO at least 60% predicted or oxygen saturation at least 92% if pulmonary function tests cannot be performed
- Total bilirubin at or below twice the upper limit of normal unless disease- or medication-related
- ALT and AST at or below twice the upper limit of normal unless disease- or medication-related
- Serum creatinine within normal range for age or creatinine clearance over 40 mL/min/1.73m2
- Informed consent or guardian permission obtained
- Donor is at least 14 years old and available in the United States
- Donor agrees to donate bone marrow or peripheral blood stem cells
- Donor meets all applicable eligibility and testing requirements
You will not qualify if you...
- Active central nervous system disease not cleared before conditioning
- Participation in other experimental protocols for GVHD prevention
- Body weight over 100 kg for matched related donor recipients
- Body weight over 75 kg for matched unrelated donor recipients without prior discussion
- HIV positive status
- Uncontrolled infections not deemed suitable for transplant
- Life expectancy less than 3 months from non-leukemia or non-myelodysplastic syndrome causes
- Significant medical conditions making transplant unsuitable
- Prior allogeneic or autologous hematopoietic cell transplant
- Pregnancy or breastfeeding in female participants
- Childbearing age participants unwilling to use birth control or abstain from sexual intercourse during treatment and for 12 months after transplant
- Known allergy to tacrolimus, fludarabine, or methotrexate
AI-Screening
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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
Research Team
M
Marie Bleakley
CONTACT
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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