Severe Toxicity Free Survival Following Childhood Acute Lymphoblastic Leukemia

Survival rates for childhood acute lymphoblastic leukemia (ALL) exceeds 90%, making a growing population of survivors susceptible to treatment-related late-effects of which some are both severe and disabling. However, late effects are not captured systematically, hence hampering the quantification of long-term toxicity. An international collaboration of ALL consortia recently defined 21 severe health conditions designated Severe Toxicities representing the objectively most severe toxicities following ALL treatment, which should be captured and included in the evaluation of the burden of therapy in the form of Severe Toxicity Free Survival (STFS).With this study we aim to evaluate the prevalence of 21 Severe Toxicities and the according Severe Toxicity Free Survival in 5 cohorts each consisting of > 1000 pediatric ALL patients across Europe, USA, and Australia. This will be the first step in the global implementation of a consensus-based reporting of late effects following ALL treatment allowing future treatment outcome evaluation to include severe toxicities.

Inclusion Criteria:1.0-17.9 years of age at time of ALL diagnosis≥5 years after ALL diagnosisPatients receiving hematopoietic stem cell transplantation are includedPatients with relapse and/or resistant disease are includedCohort sizes >1,000 patientsExclusion Criteria:None