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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.
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.
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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Shares Myelodysplastic syndromes / neoplasms (MDS) and the tag soc-trials.
Shares Novartis and the tag soc-trials.
Shares Lower-risk myelodysplastic syndromes, Myelodysplastic syndromes / neoplasms (MDS).
Shares Lower-risk myelodysplastic syndromes, Myelodysplastic syndromes / neoplasms (MDS).
Shares Myelodysplastic syndromes / neoplasms (MDS), Novartis.
Shares Lower-risk myelodysplastic syndromes, Myelodysplastic syndromes / neoplasms (MDS).
Shares Lower-risk myelodysplastic syndromes, Myelodysplastic syndromes / neoplasms (MDS).