AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia

acute lymphoblastic leukemia in children and adolescents

For the randomized study questions, the primary endpoint will be the time from randomization until the first event defined as follows: Randomization R-eHR, R-HR and R-T: Cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time., Randomization R-MR: Relapse, second malignancy or death from any cause. This will be called DFS time., EFS and DFS time: end of study

Survival starting at the same time point as the EFS/DFS, Frequency and incidence of treatment-related mortality in induction or CCR, Frequency and incidence of AE of interest and SAE in specific protocol phases, randomized arms and overall during follow-up, MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T), MRD load after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR), Proportion of patients with poor MRD response to the first Blinatumomab cycle ("Blinatumomab Poor-Response") (R HR)

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