KCT0009323
Not yet recruiting
未知
Treatment of newly diagnosed high risk pediatric acute lymphoblastic leukemia-prospective, nationwide, multi-center study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Enrollment
- 370
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •? 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
Outcomes
Primary Outcomes
Not specified
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