Treatment of pediatric very high-risk acute lymphoblastic leukemia in Korea
- Conditions
- Neoplasms
- Registration Number
- KCT0009352
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 74
Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
- Philadelphia chromosome-positive t(9;22)(q34;q11) or
- Patients with failed remission who had blast >5% on bone marrow test after initial remission induction therapy or
- Hypodiploidy (Number of chromosomes < 44 (less than 44)) or
- E2A-HLF translocation-positive or
- When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients
(i) In B-ALL, the NGS-MRD after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more,
(ii) In T-ALL, NGS-MRD is more than 0.01% after consolidation therapy
-Participants with contraindications to medications
-When the study participant or their legal representative withdraws consent
-Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
-Participants who are medically unsuitable to participate in this study at the discretion of the investigator
Participants participating in other interventional studies other than this protocol
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival
- Secondary Outcome Measures
Name Time Method Overall survival;Recurred rate;Death rate related to infusion;Adverse Event;The rate of Hematopoietic stem cell transplantation