Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-T11 and Japan Adult Leukemia Study Group (JALSG) T-ALL-211-U ALL-T11: A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia
Phase 2
Recruiting
- Conditions
- T-cell Acute Lymphoblastic Leukemia
- Registration Number
- JPRN-UMIN000006851
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 147
Inclusion Criteria
Not provided
Exclusion Criteria
1) CNS hemorrage more than grade 3 of CACAE v3.0 2) uncontrolled infection, including active tuberculosis and positive of HIV antibody. 3) pregnancy or high possibility of pregnancy and giving suck wiman. 4) history of congenital or acquired immunodeficiency. 5) Down syndrome. 6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds. 7) any inappropriate status judged by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) 3 years event free survival 2) MRD disappearance of VHR group in RCT
- Secondary Outcome Measures
Name Time Method 1) Overall survival (OS) 2) Remission induction rate 3) Adverse event (including acute and late effect of patients diagnosed at less than 18 years old)