ALLTogether1

• R1 - SR standard arm

  Standard risk arm receiving standard treatment (Delayed Intensification including Doxorubicin).

• R1 - SR experimental arm

  Standard risk arm, receiving Delayed Intensification without Doxorubicin.

• R2 - IR-low standard arm

  Standard treatment with Delayed Intensification including Doxorubicin and Maintenance including Vincristine+Dexamethasone pulses.

• R2 - IR-low experimental arm A

  Standard treatment with omission of Doxorubicin in the Delayed Intensification phase.

• R2 - IR-low experimental arm B

  Standard treatment with omission of monthly pulses of Vincristine and Dexamethasone in the Maintenance Phase.

• R3 - IR-high standard arm

  Intermediate risk high arm receiving Standard Maintenance Therapy.

Primary

• Event-free survival5 years

• Disease-free survival8 years

• Minimal residual disease responseEnd of first Blinatumomab infusion +/- 1 week

Secondary

• Overall survival8 years

• Induction deathDay 29 to Day 134

• Resistant diseaseDay 29 to Day 134

• Cumulative incidence of relapse8 years

• Cumulative incidence of second malignant neoplasm8 years

• Cumulative incidence of death in complete remission8 years

• Cumulative incidence of treatment-related mortality8 years

• Leukaemia specific mortality8 years