RecruitingPhase IIEN originalLeukemia

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment. In addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Dziecko ma mniej niż 1 rok w momencie diagnozy.
  • Dziecko ma zdiagnozowaną ostrą białaczkę limfoblastyczną (ALL) lub ostrą białaczkę z dominacją limfocytów (ALAL).
  • Rodzice (opiekunowie) wyrazili zgodę na udział dziecka w badaniu.

✗ Disqualifies

  • Dziecko ma inną odmianę białaczki niż ALL lub ALAL.
  • Dziecko ma zespół Downa, zespół Blooma, ataksję-teleangiektazję, anemię Fanconiego, zespół Kostmanna, zespół Shwachmana lub inne choroby szpiku.
  • Dziecko przechodziło wcześniej przeszczep komórek macierzystych.
  • Dziecko choruje na białaczkę, która powróciła.
  • Dziecko otrzymało leki steroidowe w ciągu ostatnich 4 tygodni (chyba że było to w nagłym przypadku onkologicznym po ustaleniu diagnozy i grupy ryzyka).

Simplified criteria — AI translation

Trial details

Maximum age
2 Years
Last updated (source)
July 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (10)

Kyungpook National University Chilgok-Hospital

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Jeju National University Hospital

Jeju City, South Korea

Pusan National University Yangsan Hospital

Pusan, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Cente

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul saint Mary's Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.

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