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New hope for kids after transplant: study tests safer GVHD prevention

NCT ID NCT05579769

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

3 people

The number who actually took part.

Started

Mar 2023

Finished

May 2024

Lead sponsor

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

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

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