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EBMT 2025 | Fludarabine plus treosulfan conditioning for AML: interim analysis of the FT14 study
Vera Radici, MD, ASST Spedali Civili Hospital, Brescia, Italy, discusses the safety and efficacy of the FT14 conditioning regimen, consisting of fludarabine and treosulfan, for patients with acute myeloid leukemia (AML) in first complete remission (CR1). Dr Radici highlights that the interim analysis of the FT14 study, a multicenter Phase II trial, demonstrated that the FT14 led to high engraftment rates, low rates of relapse, and an encouraging leukemia-free survival (LFS) rate of 88% at one year. These results suggest that FT14 conditioning could be a viable alternative to FB4 (fludarabine plus busulfan) in this setting. This interview took place at the 51st Annual Meeting of the EBMT in Florence, Italy.
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Transcript
The FT14 trial is an Italian multicenter Phase II trial that wants to evaluate the safety and efficacy of the FT14 regimen for acute myeloid leukemia patients aged 40 to 65 years in first complete remission. It was a collaborative effort of 13 Italian GITMO centers. We enrolled 65 patients and 62 received hematopoietic stem cell transplantation. And the FT14 regimen consists of fludarabine, 30 mg per meter squared for 5 days, and treosulfan, 14 grams for 3 days...
The FT14 trial is an Italian multicenter Phase II trial that wants to evaluate the safety and efficacy of the FT14 regimen for acute myeloid leukemia patients aged 40 to 65 years in first complete remission. It was a collaborative effort of 13 Italian GITMO centers. We enrolled 65 patients and 62 received hematopoietic stem cell transplantation. And the FT14 regimen consists of fludarabine, 30 mg per meter squared for 5 days, and treosulfan, 14 grams for 3 days. And our interim analysis suggests that FT14 regimen is a safe and effective regimen in older fit patients with acute myeloid leukemia undergoing HSCT. And we find that the relapses are very low and the FT14 regimen is also associated with a high engraftment rate. In terms of leukemia-free survival that was the first objective of the study it was 88% at one year, so a very encouraging result. So the result obtained in this trial and this interim analysis suggests that FT14 could be a promising alternative to FB4 in this setting.
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