Conditions: Acute Lymphoblastic Leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

Brief summary:
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: inotuzumab ozogamicin intervention 2: FLAG (fludarabine, cytarabine and G-CSF) intervention 3: HIDAC (high dose cytarabine) intervention 4: cytarabine and mitoxantrone
Intervention descriptions: intervention 1: Dose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6 intervention 2: Dose: cytarabine 2.0 g/m\^2/day IV days 1-6 fludarabine30 mg/m\^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4 intervention 3: cytarabine 3 g/m\^2 IV every 12 hours for up to 12 times intervention 4: mitoxantrone 12 mg/m\^2 IV days 1-3 cytarabine 200 mg/m\^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4

Protocol document: