BMT CTN 1102: biologic assignment trial of reduced-intensity transplant by donor availability in patients aged 50 to 75 with advanced myelodysplastic syndrome
Older people with higher-risk myelodysplastic syndrome who had a matched donor and went on to a reduced-intensity stem-cell transplant were much more likely to be alive three years later than those without a donor treated with drugs, which makes transplant part of standard planning for fit patients up to 75.
Overview
Multicentre biologic assignment trial of the Blood and Marrow Transplant Clinical Trials Network: 384 patients aged 50 to 75 with intermediate-2 or high-risk de novo myelodysplastic syndrome enrolled at 34 centres between 2014 and 2018 were assigned to the donor arm (reduced-intensity allogeneic transplant) or the no-donor arm (hypomethylating therapy or best supportive care) according to whether a matched donor was identified within 90 days.
In the intention-to-treat analysis, adjusted three-year overall survival was 47.9 percent in the donor arm against 26.6 percent in the no-donor arm (absolute difference 21.3 percentage points), and leukaemia-free survival 35.8 against 20.6 percent. The benefit was seen across all subgroups examined.
- Adjusted three-year overall survival 47.9 percent (95% CI 41.3 to 54.1) with a donor versus 26.6 percent (18.4 to 35.6) without (p 0.0001).
- Three-year leukaemia-free survival 35.8 versus 20.6 percent (p 0.003).
- Survival benefit consistent across all subgroups.
Allogeneic transplant should be included in the management plan of fit older adults with higher-risk myelodysplastic syndrome; donor search should start at diagnosis.
- Assignment by donor availability rather than randomisation; not every donor-arm patient was transplanted and the analysis is by intention to treat.
- Reduced-intensity conditioning only.
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