Actively Recruiting
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
Led by Yonsei University · Updated on 2025-07-03
40
Participants Needed
8
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The age of diagnosis is less than 1 year old
- Diagnosis of acute lymphoblastic leukemia (ALL) or acute leukemia of ambiguous lineage (lymphoid predominant)
- Informed consent given by parents or guardians before participation
You will not qualify if you...
- Burkitt leukemia/lymphoma or mature B-cell leukemia
- Presence of Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes
- Prior hematopoietic stem cell transplantation
- Relapsed infant leukemia
- Contraindications to medication
- Received systemic steroid therapy within 4 weeks prior to study
- Participation in other interventional studies besides this protocol
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Actively Recruiting
2
Jeju National University Hospital
Jeju City, South Korea
Actively Recruiting
3
Pusan National University Yangsan Hospital
Pusan, South Korea
Actively Recruiting
4
Asan Medical Center
Seoul, South Korea
Actively Recruiting
5
Samsung Medical Cente
Seoul, South Korea
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
7
Seoul saint Mary's Hospital
Seoul, South Korea
Actively Recruiting
8
Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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