Treatment of high risk pediatric acute lymphoblastic leukemia
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 370
Age: Under 19years of age at diagnosis
- Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
? High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 109/L at diagnosis
? If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
? High-risk gene variants:
KMT2A rearrangement
intrachromosomal amplification of chromosome 21 (iAMP21)
- Newly diagnosed T cell
? Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
? Patients with Down syndrome
? potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
? Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
? Participating in an interventional clinical trial other than this research
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