International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Trial Parameters
Brief Summary
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.
Eligibility Criteria
Inclusion Criteria: * Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL * Children less than 18 years of age at date of inclusion into the study * Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse) * Patient enrolled in a participating centre * Written informed consent * Start of treatment falling into the study period * No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL Exclusion Criteria: * Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL * Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \> 10 U/l) * Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy * Breast feeding * Relapse post allogeneic stem-cell transplantation * Ne