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Study identifier: NCT06516679 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Recruiting

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

Condition: Leukemia, Lymphoid  ·  Sponsor: Yonsei University

PhasePhase 2
Planned participants40
Who can joinAll sexes, N/A to 2 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where10 locations

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * The age of diagnosis is less than 1 year old * The disgnosisi of ALL or ALAL(lymphoid predominant) * Informed consent of the parents(guardians) before participation in this study Exclusion Criteria: * Burkitt leukemia/lymphoma or mature B-cell leukemia * Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation * Relapsed infant leukemia * Participants with contraindication to medication * Administered systemic steroid therapy within 4 weeks prior to this study (However, steroid administration is allowable in oncologic emergencies only after the subject's disease diagnosis and risk group classification are completed.) * Participants in other interventional studies other than this protocol

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (10)

Kyungpook National University Chilgok-HospitalDaegu, South KoreaNot Yet Recruiting
Chungnam National University HospitalDaejeon, South KoreaNot Yet Recruiting
Chonnam National University Hwasun HospitalHwasun, South KoreaRecruiting
Jeju National University HospitalJeju City, South KoreaRecruiting
Pusan National University Yangsan HospitalPusan, South KoreaRecruiting
Asan Medical CenterSeoul, South KoreaRecruiting
Samsung Medical CenteSeoul, South KoreaRecruiting
Seoul National University HospitalSeoul, South KoreaRecruiting
Seoul saint Mary's HospitalSeoul, South KoreaRecruiting
Severance HospitalSeoul, South KoreaRecruiting

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

HwasunJeju CityPusanSeoul

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