AALL1731
Trial question
What is the role of addition of blinatumomab to combination chemotherapy in pediatric patients with newly diagnosed standard-risk B-cell acute lymphoblastic leukemia of average or high risk of relapse?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 1440
1440 patients (682 female, 758 male).
Inclusion criteria: pediatric patients with newly diagnosed standard-risk B-cell acute lymphoblastic leukemia of average or high risk of relapse.
Key exclusion criteria: secondary acute lymphoblastic leukemia; receipt of prior cytotoxic chemotherapy; receipt of > 72 hours of hydroxyurea within 1 week prior to the start of systemic protocol therapy; acute undifferentiated leukemia; known Charcot-Maire-Tooth disease; requirement of radiation at diagnosis.
Interventions
N=718 blinatumomab and chemotherapy (two nonsequential 28-day cycles of blinatumomab plus chemotherapy).
N=722 chemotherapy alone (standard combination chemotherapy alone).
Primary outcome
Mean disease-free survival at 3 years
1606 days
1534 days
1606.0 days
1204.5 days
803.0 days
401.5 days
0.0 days
Blinatumomab and
chemotherapy
Chemotherapy
alone
Significant
increase ▲
Significant increase in mean disease-free survival at 3 years (1606 days vs. 1534 days; MD 72, 95% CI 36 to 108).
Safety outcomes
No significant differences in infectious adverse events, sepsis and catheter-related infections grade ≥ 3 in patients with high risk of relapse.
Significant differences in sepsis and catheter-related infections grade ≥ 3 in patients with average risk of relapse (14.8% vs. 5.1%), allergic reactions grade ≥ 3 in patients with an average risk of relapse (2.8% vs. 7.2%).
Conclusion
In pediatric patients with newly diagnosed standard-risk B-cell acute lymphoblastic leukemia of average or high risk of relapse, blinatumomab and chemotherapy were superior to chemotherapy alone with respect to mean disease-free survival at 3 years.
Reference
Sumit Gupta, Rachel E Rau, John A Kairalla et al. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2024 Dec 7. Online ahead of print.
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