Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults with Blood Cancers

This study is looking at whether removing certain immune cells, called naive T cells, from donor stem cells can prevent chronic graft-versus-host disease (GVHD) in children and young adults with blood cancers. GVHD happens when the transplanted donor cells attack your body. Participants will receive one of three chemotherapy regimens using drugs like Total-Body Irradiation, Thiotepa, Fludarabine, Cyclophosphamide, or Busulfan. Then, some will receive donor stem cells with naive T cells removed, while others will receive standard donor stem cells. The study aims to see if this approach is practical and if it helps patients avoid GVHD and relapse for at least one year. You may be eligible if you are between 6 months and 26 years old with certain types of acute leukemia.

Study design: This is a randomized study, meaning participants are assigned by chance to one of two treatment groups. The study plans to enroll 68 participants.
What's involved: You will undergo various chemotherapy treatments, receive a stem cell transplant, and have regular blood tests, echocardiograms (ECHO), and cerebrospinal fluid (CSF) collections throughout the trial.
Compensation: Not stated in the trial record.
Follow-up: The study will track your progress for up to two years to assess the feasibility of the treatment and for at least one year to measure GVHD-free, relapse-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

Recruiting

PHASE2Ages 6–26InterventionalTreatment

Fred Hutchinson Cancer Center

~68 participants

Updated 2026-07-29 on ClinicalTrials.gov

What's tested:Total-Body IrradiationThiotepaFludarabineCyclophosphamideBusulfanAllogeneic Bone Marrow Transplantation

At a glance

Recruiting sites

5 of 10 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Feasibility achievement

Measured over Up to 2 years

+2 more outcomes measured

Conditions

Acute Biphenotypic Leukemia

Acute Leukemia

Acute Leukemia of Ambiguous Lineage

Acute Lymphoblastic Leukemia

Acute Undifferentiated Leukemia

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Blastic Plasmacytoid Dendritic Cell Neoplasm

Blasts Under 25 Percent of Bone Marrow Nucleated Cells

Blasts Under 5 Percent of Bone Marrow Nucleated Cells

Mixed Phenotype Acute Leukemia

Myelodysplastic Syndrome With Excess Blasts-1

Myelodysplastic Syndrome/Acute Myeloid Leukemia

Burkitt Leukemia

Chronic Monocytic Leukemia

Lymphoblastic Lymphoma

Mast Cell Leukemia

Myeloproliferative Neoplasm

Where it's being run

10 sites across 9 states

Ohio2

California1

District of Columbia1

Georgia1

Iowa1

Massachusetts1

Oregon1

Pennsylvania1

Study leadership

Marie Bleakley · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Marie Bleakley

[email protected]

206-667-6572

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Eligibility criteria

Inclusion

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 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form

Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8/8 match for human leukocyte antigen \[HLA\]-A, -B, -C, -DRB1).

Planned product type for infusion is PBSC or BM (i.e. not cord blood):

For feasibility phase, planned product type for infusion must be PBSC.

For RCT, planned product type must be PBSC or BM.

Karnofsky or Lansky score \>= 60%.

Left ventricular ejection fraction (LVEF) at rest \>= 40%.

Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \>= 60% predicted by pulmonary function tests (PFTs)

Total bilirubin =\< 2 x upper limit of normal (ULN) (unless value\[s\] \> 2 x ULN are disease- or medication-related).

Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\< 2 x ULN (unless value\[s\] \> 2 x ULN are disease- or medication-related).

Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \> 40 mL/min/1.73m\^2 must be obtained (measured by 24-hour \[hr\] urine specimen or nuclear glomerular filtration rate \[GFR\]).

Age (Years): Maximum SCr (mg/dL)

=\< 5: 0.8

6-10: 1

11-15: 1.2

\> 15: 1.5

Recipient informed consent/assent/legal guardian permission documentation must be obtained.

DONOR: May be related (MRD) or unrelated (MUD) to the subject.

DONOR: Must be matched to the subject at 8/8 HLA alleles (HLA-A, -B, -C, and -DRB1)

DONOR: Be \>=14 years of age.

DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).

DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).

DONOR: MUDs:

Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements

Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))

Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory

DONOR: MRDs:

Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and/or nucleic acid testing \[NAT\] and/or other approved testing)

Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).

Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.

Exclusion

Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.

Patients on other experimental protocols for the prevention of GVHD.

Patient body weight:

Matched related donor (MRD): \> 100 kg are ineligible

Matched unrelated donor (MUD): \> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.

HIV-positive.

Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.

Life expectancy \< 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).

Significant medical condition that would make recipient unsuitable for HCT.

Prior allogeneic or autologous HCT.

Females who are pregnant or breastfeeding.

Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.

Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).

What this trial measures

Feasibility achievementUp 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)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])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.

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