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NCT06516679RecruitingPhase 2

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
27 Jun 2024
Start date
11 Dec 2024
Primary completion date
31 Aug 2032
Lead sponsor
Yonsei University
NCT number
NCT06516679

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 11 Dec 2024 to the primary completion date, 31 Aug 2032
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.)

Other illness

  • Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation

Other

  • Burkitt leukemia/lymphoma or mature B-cell leukemia
  • Relapsed infant leukemia
  • Participants in other interventional studies other than this protocol

Who the study is looking for

  • 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

Age in the registry: - to 2 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kyungpook National University Chilgok Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaNot yet recruiting
Chungnam National University Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaNot yet recruiting
Chonnam National University Hwasun Hospital
Coordinator of this site? Confirm its status
HwasunSouth KoreaRecruiting
Jeju National University Hospital
Coordinator of this site? Confirm its status
Jeju CitySouth KoreaRecruiting
Pusan National University Yangsan Hospital
Coordinator of this site? Confirm its status
PusanSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Cente
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul saint Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.