New hope for kids after transplant: study tests safer GVHD prevention
NCT ID NCT05579769
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a new way to prevent severe graft-versus-host disease (GVHD) in children who had a bone marrow transplant for blood cancers. The goal was to see if stopping certain immune-suppressing drugs after day 60 could lower the risk of severe GVHD. Only 3 children took part before the study was ended early. The approach aimed to control the disease while reducing long-term side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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3 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria Diagnosis: * Patients with high risk acute lymphoblastic leukemia in first remission. Examples include, but are not limited to, patients with certain leukemic cell cytogenetic findings (e.g. t(9;22) or t(4;11)); delayed response to induction chemotherapy; re-emergence of leukemic blasts by MRD (at any level) in patients previously MRD negative; persistently detectable MRD at lower levels; early T-cell precursor (ETP) ALL. * Patients with acute lymphoblastic leukemia beyond first remission. * Patients with Hodgkin's disease beyond first remission or with refractory disease. * Patients with chronic myelogenous leukemia. * Patients with primary or secondary myelodysplastic syndrome. * Patients with Non-Hodgkin's lymphoma beyond first remission or with refractory disease. * Patients with de novo acute myeloid leukemia in or beyond first remission or with relapsed or refractory disease, or myeloid sarcoma (extra-medullary AML). * Patients with secondary acute myeloid leukemia. * NK cell lymphoblastic leukemia in any CR. * Biphenotypic, bilineage, or undifferentiated leukemia. * Juvenile Myelomonocytic Leukemia (JMML) * All patients with prior evidence of CNS leukemia must be treated and be in CNS CR. Patients must have a related or unrelated donor matched at 12 of 12 HLA alleles. Patient must have a Karnofsky/Lansky score of 70 or higher. Patients must be 12 years of age or older. Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%. Patients must have bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal. Patients must have creatinine clearance, or a glomerular filtration rate (GFR), greater than 70 mL/min/1.73m2. Patients must be free of severe infection that upon determination of principal investigator precludes BMT. Patients must have FVC \>50% predicted OR, if unable to perform pulmonary function testing, must maintain pulse oximetry oxygen saturation \>92% on room air. Female patients of childbearing age must have a negative pregnancy test. Exclusion criteria * Patients who have undergone prior HCT. * Patients who have a peripheral blood stem cell graft source. * Patients who have a non-permissive mismatch at the DPB1 allele. * Patients who are HIV positive. * Patients positive for Hepatitis B surface antigen (HBsAg). * Patients positive for Hepatitis C. * Patients with latent tuberculosis with positive TB IFN gamma release assay.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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