TELESTO
TELESTO is the only placebo-controlled trial of removing excess iron in people with lower-risk myelodysplastic syndrome who depend on blood transfusions; the chelator deferasirox lengthened the time before heart or liver damage, progression to leukaemia or death by about a year.
Overview
TELESTO was a randomised, double-blind, placebo-controlled trial run by Novartis in 225 patients with low- or intermediate-1-risk myelodysplastic syndrome and iron overload from repeated red cell transfusions. Patients received deferasirox, an oral iron chelator with no record in this corpus, or placebo. The primary endpoint was event-free survival, a composite of non-fatal cardiac and hepatic events, progression to acute myeloid leukaemia and death. Recruitment was slow and the design was reduced from a phase 3 to a phase 2 trial.
Median event-free survival in the registry results was 1,440 days with deferasirox against 1,091 days with placebo, a hazard ratio of 0.636, and the difference was statistically significant. The trial is the randomised evidence behind iron chelation for transfusional iron overload on the corpus's myelodysplastic syndrome page.
- Deferasirox: 1440 days; Placebo: 1091 days.
- Put another way, the treated group had about 36 percent lower chance of the event at any given time (hazard ratio 0.636, likely range 0.42 to 0.96).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Low- or intermediate-1-risk myelodysplastic syndrome with transfusional iron overload: the oral iron chelator deferasirox or placebo (double-blind), with event-free 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.
225 enrolled.
95% CI 1,167 to 1,559 days · 95% CI 820 to 1,348 days
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (non-fatal cardiac or hepatic event, progression to acute myeloid leukaemia, or death)primary | Deferasirox | - | 1440 days | 0.636 (0.42 to 0.96) | 0.015 | link |
| Placebo | - | 1091 days |
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