BMT CTN 1102
BMT CTN 1102 settled whether older people with higher-risk myelodysplastic syndrome should be offered a stem-cell transplant: those who had a matched donor and went to transplant were far more likely to be alive three years later than those without a donor who had drug treatment instead, so transplant belongs in the plan for fit patients aged 50 to 75.
Overview
BMT CTN 1102 was a multicentre biologic assignment trial of the Blood and Marrow Transplant Clinical Trials Network in 384 patients aged 50 to 75 with intermediate-2 or high-risk de novo myelodysplastic syndrome enrolled at 34 centres between 2014 and 2018. Patients 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 found within 90 days of registration. The primary endpoint was overall survival at three years by intention to treat.
Adjusted three-year overall survival was 47.9 percent in the donor arm against 26.6 percent in the no-donor arm, an absolute difference of 21.3 percentage points, and leukaemia-free survival was 35.8 against 20.6 percent; the benefit held across every subgroup examined. The trial is the evidence that reduced-intensity transplant should be an integral part of management for fit older adults with higher-risk disease, which is how the corpus's myelodysplastic syndrome page cites it.
- 47.9 vs 26.6 out of 100 alive at 3 years with Donor arm: reduced-intensity allogeneic transplant compared with No-donor arm: hypomethylating therapy or best supportive care; 21.3 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 35.8 vs 20.6 out of 100 alive at 3 years with Donor arm: reduced-intensity allogeneic transplant compared with No-donor arm: hypomethylating therapy or best supportive care; 15.2 more per 100.
- Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.003) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Intermediate-2 or high-risk de novo myelodysplastic syndrome in patients aged 50 to 75: assignment by donor availability within 90 days to reduced-intensity allogeneic transplant or to hypomethylating therapy or best supportive care, with three-year overall survival as the primary endpoint. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
384 enrolled.
95% CI 41.3 to 54.1 · 95% CI 18.4 to 35.6
Source95% CI 29.8 to 41.8 · 95% CI 13.3 to 29.1
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 3 years (intention to treat, adjusted)primary | Donor arm: reduced-intensity allogeneic transplant | - | 47.9% | - | 0.0001 | link |
| No-donor arm: hypomethylating therapy or best supportive care | - | 26.6% | ||||
| Leukaemia-free survival at 3 years | Donor arm: reduced-intensity allogeneic transplant | - | 35.8% | - | 0.003 | link |
| No-donor arm: hypomethylating therapy or best supportive care | - | 20.6% |
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