NCT03779854 · Fred Hutchinson Cancer Center
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
What this study 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).
View original scientific description
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.
Interventions
RADIATION
Total-Body Irradiation
Undergo TBI
DRUG
Thiotepa
Given IV
DRUG
Fludarabine
Given IV
DRUG
Cyclophosphamide
Given IV
DRUG
Busulfan
Given IV
PROCEDURE
Allogeneic Bone Marrow Transplantation
Receive unmanipulated T cell replete BM
DRUG
Tacrolimus
Given IV
DRUG
Methotrexate
Given IV
PROCEDURE
Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation
Receive naive T-cell depleted PBSCs
PROCEDURE
Echocardiography
Undergo ECHO
PROCEDURE
Biospecimen Collection
Undergo CSF and blood sample collection
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow biopsy
Primary outcome measures
Feasibility achievement
Time frame: Up to 2 years
Success defined as achievement of cell selection goals for two consecutive Naive T cells (TN)-depleted peripheral blood stem cells (PBSC) hematopoietic cell transplantation (HCTs) at each study site (Feasibility)
Engraftment of neutrophils by day 28 (Feasibility)
Time frame: At day 28
Success defined as achievement neutrophil engraftment (absolute neutrophil count \[ANC\] \>= 500/mm\^3) on first day of three consecutive laboratory values obtained on different days.
Current-graft versus host disease (GVHD)-free, relapse-free survival (Randomized Controlled Trial [RCT])
Time frame: At 1 year
Defined as alive, no relapse after HCT, no current GVHD requiring prednisone, no graft rejection or graft failure. The proportion of subjects meeting the primary endpoint will be described in each arm with 90% confidence intervals (CI) and compared between arms using the chi-square test. A two-sided 10% significance level will be used for this comparison.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):
- Acute lymphoblastic leukemia (ALL) with \< 5% marrow blasts.
- Acute myeloid leukemia (AML) with \< 25% marrow blasts.
- Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \[ABL\], ambiguous lineage \[ALAL\], mixed phenotype acute leukemia \[MPAL\], blastic plasmacytoid dendritic cell neoplasm \[BPDCN\], acute undifferentiated leukemia \[AUL\], lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia, chronic monocytic leukemia \[CML\] with blast crisis or other chronic myeloproliferative neoplasm) with \< 5% marrow blasts.
- Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)
- Age 6 months to 2
Where
- Los Angeles, California
- Washington D.C., District of Columbia
- Atlanta, Georgia
- Iowa City, Iowa
- Boston, Massachusetts
- Cleveland, Ohio
- Portland, Oregon
- Pittsburgh, Pennsylvania
- Seattle, Washington
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations