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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.
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.
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.
Shares AALL1331, Relapsed and refractory acute lymphoblastic leukaemia in children, Blinatumomab, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Blinatumomab, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Blinatumomab, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Blinatumomab, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Acute lymphoblastic leukaemia.