ESH CML/MPN 2025 | The Phase II HALF study: investigating a gradual TKI treatment discontinuation strategy in CML
Daniela Žáčková, MD, PhD, Masaryk University, Brno, Czechia, introduces the ongoing prospective multicentre Phase II HALF trial (NCT04147533) investigating a gradual tyrosine kinase inhibitor (TKI) treatment discontinuation strategy in patients with chronic myeloid leukemia (CML). The study aims to improve treatment discontinuation outcomes, including increasing the treatment-free remission (TFR) rate, reducing the severity of TKI withdrawal syndrome, and identifying biomarkers for TFR success. Dr Žáčková reports that the trial has successfully enrolled 207 patients, and data are currently being analyzed. This interview took place at the European School of Haematology (ESH) 4th How to Diagnose and Treat: CML/MPN meeting in Vienna, Austria.
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Transcript
There are still some unmet needs also on the TKI discontinuation topic, so that’s why this HALF trial was designed differently. HALF means that the TKI dose is reduced for the first half year and then for the next half year the same dose is given alternatively or every other day and then the treatment is stopped. And our aim was obvious – to improve results of the treatment discontinuation process or increase the TFR rate, decrease the severity and appearance of TKI withdrawal syndrome, improve patient perceptions, and also to identify at least some markers, especially biomarkers for TFR success because we know that this is also an issue not yet addressed...
There are still some unmet needs also on the TKI discontinuation topic, so that’s why this HALF trial was designed differently. HALF means that the TKI dose is reduced for the first half year and then for the next half year the same dose is given alternatively or every other day and then the treatment is stopped. And our aim was obvious – to improve results of the treatment discontinuation process or increase the TFR rate, decrease the severity and appearance of TKI withdrawal syndrome, improve patient perceptions, and also to identify at least some markers, especially biomarkers for TFR success because we know that this is also an issue not yet addressed.
So when we started this trial, it was during COVID, so it was not a very easy task, but currently, we have already closed the recruitment, and we enrolled altogether 207 patients, which is really outstanding enrollment. We are very proud of it and currently we are analyzing the data and what I can say is that they look nice. Now it’s not possible to tell you more, but we hope we will have a chance to present the data during the EHA Congress in Milan in June this year.
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Disclosures
Consultantancy: Angelini, Zentiva, Novartis; Speakers’ bureau: Angelini, Novartis, Scientific advisory board: Ascentage, Enliven Therapeutics, Novartis, Zentiva.
