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
- Diseases
- Childhood cancers
- 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
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Not yet recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Not yet recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Recruiting |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Recruiting |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Pusan | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Cente Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul saint Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.