Childrens Cancer and Leukemia Study Group (CCLSG) ALL2004 : A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Lymphoblastic Leukemia
Phase 2
- Conditions
- Childhood acute lymphoblastic leukemia
- Registration Number
- JPRN-UMIN000010488
- Lead Sponsor
- Childhood Cancer and Leukemia Study Group (CCLSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
Not provided
Exclusion Criteria
1) mature B-ALL 2) Ph+ALL : After registration, stop the protocol study with information of Ph+. 3) organ dysfunction for attending protocol study. 4) pregnancy or high possibility of pregnancy and giving suck woman. 5) history of congenital or acquired immunodeficiency. 6) uncontrollable infection 7) any inappropriate status judged by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint 1) 3 years event free survival(3y-EFS) 1.1.3y-EFS difference between Point1:MRD(-) with Point2:MRD(-) group and Point1:MRD(+) with Point2:MRD(-) group 1.2.3y- EFS improving by the salvage therapy for Point2:MRD(+) group
- Secondary Outcome Measures
Name Time Method Secondary endpoint 1)Severe adverse event rate in each risk- classification group. 2)Relationship between early prednisolone response and Poin1- and Point2-MRD. 3)Relationship between day15 bone marrow blast and Poin1- and Point2-MRD. 4) Relationship among Point3-,4-, 5-, 6-, 7- (at the end of protocol) MRD and relapse