Children's Oncology Group AALL1331 (low-risk relapse)
Trial question
What is the role of blinatumomab in patients with low-risk first relapse of B-cell acute lymphoblastic leukemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 255
255 patients (103 female, 152 male)
Inclusion criteria: patients aged 1-30 years with low-risk first relapse of B-cell acute lymphoblastic leukemia
Key exclusion criteria: Down syndrome; Philadelphia chromosome-positive acute lymphoblastic leukemia; prior HSCT; prior blinatumomab treatment
Interventions
N=127 blinatumomab (blinatumomab 15 mcg/m²/day IV plus chemotherapy)
N=128 chemotherapy (standard chemotherapy alone)
Primary outcome
Disease-free survival at 4 years
61.2
49.5
61.2 %
45.9 %
30.6 %
15.3 %
0.0 %
Blinatumomab
Chemotherapy
No significant
difference ↔
No significant difference in disease-free survival at 4 years (61.2% vs. 49.5%; HR 0.76, 95% CI 0.51 to 1.14)
Secondary outcomes
No significant difference in overall survival at 4 years (90.4% vs. 79.6%; HR 0.65, 95% CI 0.32 to 1.3)
Significant increase in disease-free survival for bone marrow and extramedullary relapses at 4 years (72.7% vs. 53.7%; HR 1.89, 95% CI 1.05 to 3.33)
Significant increase in overall survival for bone marrow and extramedullary relapses at 4 years (97.1% vs. 84.8%; HR 3.57, 95% CI 0.98 to 12.5)
Safety outcomes
Significant differences in severe febrile neutropenia (3% vs. 48%), severe infections (5% vs. 51%), severe sepsis (0% vs. 11%), severe anemia (13% vs. 58%), severe mucositis (1% vs. 7%).
Conclusion
In patients aged 1-30 years with low-risk first relapse of B-cell acute lymphoblastic leukemia, blinatumomab was not superior to chemotherapy with respect to a disease-free survival at 4 years.
Reference
Laura E Hogan, Patrick A Brown, Lingyun Ji et al. Children's Oncology Group AALL1331: Phase III Trial of Blinatumomab in Children, Adolescents, and Young Adults With Low-Risk B-Cell ALL in First Relapse. J Clin Oncol. 2023 Sep 1;41(25):4118-4129.
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