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 now · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03779854

Run by

Fred Hutchinson Cancer Center

People needed

68

Starts

2019-08-29

Expected to finish

2028-12-31

Last updated by the study team

2026-07-29

Who can join

Age: 1 and older, up to 26. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)
• Patients who are unable to perform PFTs (age < 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be >= 92% on room air.
• Total bilirubin =< 2 x upper limit of normal (ULN) (unless value[s] > 2 x ULN are disease- or medication-related).
• If value(s) are > 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =< 2 x ULN (unless value[s] > 2 x ULN are disease- or medication-related).
• If value(s) are > 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.
• 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.

You may not qualify if…

• 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).

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (enrolling)
• UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center) — Cleveland, Ohio, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Dana Farber / Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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