AALL1331: blinatumomab versus chemotherapy consolidation in high- and intermediate-risk first relapse of childhood B-ALL
Children whose leukaemia relapsed did better when two cycles of the antibody blinatumomab replaced intensive chemotherapy before transplant: more were alive two years later and far fewer had serious infections, although the disease-free survival difference did not reach the trial's statistical threshold.
Overview
Randomised phase 3 trial of the Children's Oncology Group at 155 hospitals: 208 patients aged 1 to 30 with high- or intermediate-risk first relapse of B-cell acute lymphoblastic leukaemia were randomised after reinduction to two cycles of blinatumomab or two cycles of multi-agent chemotherapy, each followed by transplant.
Two-year disease-free survival was 54.4 percent with blinatumomab against 39.0 percent with chemotherapy (hazard ratio 0.70, one-sided p 0.03), two-year overall survival 71.3 against 58.4 percent (hazard ratio 0.62), and serious infection, febrile neutropenia, sepsis and mucositis were several times less common with blinatumomab. Randomisation was closed early on the monitoring committee's recommendation, so the primary endpoint was underpowered.
- Two-year disease-free survival 54.4 percent with blinatumomab versus 39.0 percent with chemotherapy (hazard ratio 0.70, 95% CI 0.47 to 1.03; one-sided p 0.03).
- Two-year overall survival 71.3 versus 58.4 percent (hazard ratio 0.62, 95% CI 0.39 to 0.98).
- Serious infection 15 versus 65 percent, febrile neutropenia 5 versus 58 percent, sepsis 2 versus 27 percent, mucositis 1 versus 28 percent.
Blinatumomab consolidation is a safer bridge to transplant for children with higher-risk relapsed B-ALL and improved survival; it is the basis for using blinatumomab in place of chemotherapy blocks after relapse.
- Early closure with 80 of 131 planned events; the disease-free survival difference was not statistically significant at the prespecified threshold.
- Patients with Down syndrome, Philadelphia-positive disease or prior transplant were excluded.
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