Children's Oncology Group AALL1331 (intermediate- and high-risk relapse)
Trial question
What is the role of blinatumomab in patients with intermediate- or high-risk first relapse of B-cell acute lymphoblastic leukemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 208
208 patients (97 female, 111 male)
Inclusion criteria: patients aged 1-30 years with intermediate- or high-risk first relapse B-cell acute lymphoblastic leukemia
Key exclusion criteria: Down syndrome; Philadelphia chromosome-positive acute lymphoblastic leukemia; prior HSCT; prior blinatumomab treatment
Interventions
N=105 blinatumomab (2 cycles of blinatumomab 15 mcg/m²/day continuous infusion, followed by transplant)
N=103 chemotherapy (two 4-week cycles of multiagent chemotherapy, followed by transplant)
Primary outcome
Disease-free survival at 2 years
54.4
39
54.4 %
40.8 %
27.2 %
13.6 %
0.0 %
Blinatumomab
Chemotherapy
No significant
difference ↔
No significant difference in disease-free survival at 2 years (54.4% vs. 39%; HR 1.43, 95% CI 0.97 to 2.13)
Secondary outcomes
Significant increase in overall survival at 2 years (71.3% vs. 58.4%; HR 1.6, 95% CI 1.02 to 2.56)
No significant difference in negative minimal residual disease at the end of reinduction (25% vs. 30%; OR 0.76, 95% CI 0.4 to 1.5)
Significant increase in HSCT (70% vs. 43%; OR 3.2, 95% CI 1.7 to 5.9)
Conclusion
In patients aged 1-30 years with intermediate- or high-risk first relapse B-cell acute lymphoblastic leukemia, blinatumomab was not superior to chemotherapy with respect to a disease-free survival at 2 years.
Reference
Patrick A Brown, Lingyun Ji, Xinxin Xu et al. Effect of Postreinduction Therapy Consolidation With Blinatumomab vs Chemotherapy on Disease-Free Survival in Children, Adolescents, and Young Adults With First Relapse of B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2021 Mar 2;325(9):833-842.
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