Status:
RECRUITING
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
Lead Sponsor:
Yonsei University
Conditions:
Leukemia, Lymphoid
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Infant leukemia patients are classified into low/intermediate/high risk groups and hematopoietic stem cell transplantation is performed after chemotherapy or chemotherapy as shown in the schema below....
Eligibility Criteria
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
- 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
- Participants in other interventional studies other than this protocol
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06516679
Start Date
December 11 2024
End Date
December 31 2032
Last Update
July 3 2025
Active Locations (8)
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1
Chonnam National University Hwasun Hospital
Hwasun, South Korea
2
Jeju National University Hospital
Jeju City, South Korea
3
Pusan National University Yangsan Hospital
Pusan, South Korea
4
Asan Medical Center
Seoul, South Korea