Treatment Plans for Newly Diagnosed Infant Leukemia Based on Genetic Features
Tests chemotherapy and stem cell transplant plans in infants with lymphoid leukemia.
Plain-language title generated from the registry record
Registry title: Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
Key facts
- Where
- Daegu, Daejeon, Hwasun, Jeju City, Pusan, and Seoul, South KoreaSee the 10 sites
- Phase
- Phase 2
Where in South Korea
- Kyungpook National University Chilgok HospitalDaegu, South KoreaNot yet recruiting
- Chungnam National University HospitalDaejeon, South KoreaNot yet recruiting
- Chonnam National University Hwasun HospitalHwasun, South KoreaTaking people
- Jeju National University HospitalJeju City, South KoreaTaking people
- Pusan National University Yangsan HospitalPusan, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenteSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Seoul saint Mary's HospitalSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yonsei University
- Trial code
- NCT06516679
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective 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.
Inclusion: 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: 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.); Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation; Burkitt leukemia/lymphoma or mature B-cell leukemia; Relapsed infant leukemia; Participants in other interventional studies other than this protocol.