Can matching treatment to genetic risk beat relapsed childhood leukemia?
NCT ID NCT05827549
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial is testing whether a treatment plan tailored to each child's genetic risk can improve outcomes for relapsed acute lymphoblastic leukemia. Children and young adults up to age 22 whose leukemia has returned in the bone marrow receive a combination of chemotherapy drugs, and those at high risk also get the immunotherapy blinatumomab before a stem cell transplant. The goal is to see if this risk-based approach leads to better long-term survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of chemotherapy drugs (prednisolone, vincristine, L-asparaginase, idarubicin, ifosfamide, etoposide, methotrexate, cytarabine) and the immunotherapy blinatumomab
- What this could lead to
- If successful, this approach could improve cure rates for children whose leukemia has returned, by matching treatment intensity to each child's specific risk.
- What could go wrong
- This is a Phase 2 trial, so the strategy is still experimental. The chemotherapy and immunotherapy carry significant side effects, and not all children may respond.
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
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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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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- 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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1 year to 22 years
- 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.
Show the full entry requirements Hide 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: * Patients \<= 1 year and \>22 years of age at the time of relapse will be eligible * Participants must have a histologic diagnosis of acute lymphoblastic leukemia: * B-ALL: Precursor B-cell acute lymphoblastic leukemia * T-ALL: Precursor T-cell acute lymphoblastic leukemia * 1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow. Enrolling patients with combined extra medullary relapse including bone marrow is acceptable. (No limits for extra medullary site) Additionally, subjects whose blast cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite) * Patients who have never received allogeneic stem cell transplant * Patients who have never received blinatumomab before * Adequate Renal Function -A serum creatinine based on age/gender as follows: 1 to \< 2 years - Male (0.6) Female (0.6) 2 to \< 6 years - Male (0.8) Female (0.8) 6 to \< 10 years - Male (1) Female (1) 10 to \< 13 years - Male (1.2) Female (1.2) 13 to \< 16 years - Male (1.5) Female (1.4) ≥ 16 years - Male (1.7) Female (1.4) * Adequate Liver Function defined as a direct bilirubin \<3.0 mg/dL * Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram * Lansky (age \< 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% at screening * Patients with a life expectancy of 1 or more year * Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator * Signed written informed consent and assent forms must be obtained prior to any study procedures Exclusion Criteria: * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia * Patients with Philadelphia chromosome positive (Ph+) ALL * Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab * In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study * Patients with mixed phenotype leukemia * patient who was relapsed within 1 month after the end of induction therapy with the same 4-drug regimen to be used in this study. * Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome * Patients with known HIV * Female patients who are not proved as infertile or pregnant (Evidence of infertility: History taking of possibilities of pregnancy or urine human chorionic gonadotrophin test negative, amenorrhea more than a year, Natural or artificial (Ex.hormone therapy) menopause status more than a year, surgical sterilization(Ex.Hysterectomy or ovariotomy etc) * Currently receiving treatment in another investigational drug study or clinical trial * Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients\' compliance * Patients with clinically relevant central nervous system (CNS) pathology or active CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis, aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder * Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Chonnam National University Hwasun Hospital
RECRUITINGHwasun, 58128, South Korea
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Chungnam National University Hospital
NOT_YET_RECRUITINGDaejeon, 35015, South Korea
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Jeju National University Hospital
NOT_YET_RECRUITINGJeju City, 63241, South Korea
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Kyungpook National University Chilgok Hospital
NOT_YET_RECRUITINGDaegu, 41404, South Korea
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Pusan National University Yangsan Hospital
RECRUITINGYangsan, 50612, South Korea
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Seoul saint Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New stem cell therapy aims to tame transplant complications
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