At a glance
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Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL
In Brief
A Phase 3 clinical trial evaluating Blinatumomab, Dexamethasone, and 6 other interventions for Leukemia, Acute Lymphoblastic. Completed, enrolled 111 participants across 103 sites in 24 countries.
Signals
Detailed Summary
B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.
Study Details
Timeline
Arms & Interventions
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day intravenous \[IV\] on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or intramuscularly \[IM\] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
15 μg/m\^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
Interventions
15 μg/m\^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
10 mg/m\^2/day intravenous (IV) on Days 1-6
1.5 mg/m\^2/day IV on Days 1 and 6
30 mg/m\^2 IV over 24 hours on Day 5
1 g/m\^2 IV over 36 hours on Day 1
800 mg/m\^2 IV for 1 hour on Days 2-4
1000 U/m\^2 IV for 2 hours or intramuscularly (IM) on Day 6
In case of allergic reaction to PEG-asparaginase, participants could change to erwinia-asparaginase, 20,000 units/m2 every 48 hours for a total of 6 doses