DANTE Trial Results: Novel Two-Stage Approach to Treatment-Free Remission in Chronic Myeloid Leukaemia — Clinical Implications for TKI De-escalation
247 Health News Editorial
·4 Apr 2026
·4 min read
·clinical-trialsThe completed DANTE trial investigated a novel two-stage approach to treatment-free remission in chronic myeloid leukaemia, examining dose de-escalation followed by combination salvage therapy. Results expected by October 2025 could transform CML management paradigms.
Originally reported by ClinicalTrials.gov
References
- 1.Novartis Pharmaceuticals. (2024). A Phase II, Single-arm Study of De-escalation and Treatment-free Remission in Patients With Chronic Myeloid Leukemia Treated With Nilotinib in First-line Therapy Followed by a Second Attempt After Nilotinib and Asciminib Combination: DANTE Study. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT03874858
- 2.Mahon, F. X., Réa, D., Guilhot, J., Guilhot, F., Huguet, F., Nicolini, F., Legros, L., Charbonnier, A., Guerci, A., Varet, B., Etienne, G., Reiffers, J., Rousselot, P., & Intergroupe Français des Leucémies Myéloïdes Chroniques. (2010). Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. The Lancet Oncology, 11(11), 1029-1035. https://doi.org/10.1016/S1470-2045(10)70233-3
- 3.Hochhaus, A., Saussele, S., Rosti, G., Mahon, F. X., Janssen, J. J., Hjorth-Hansen, H., Richter, J., & Hehlmann, R. (2020). Chronic myeloid leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 31(5), 563-579. https://doi.org/10.1016/j.annonc.2020.02.002
- 4.Druker, B. J., Guilhot, F., O'Brien, S. G., Gathmann, I., Kantarjian, H., Gattermann, N., Deininger, M. W., Silver, R. T., Goldman, J. M., Stone, R. M., Cervantes, F., Hochhaus, A., Powell, B. L., Gabrilove, J. L., Rousselot, P., Reiffers, J., Cornelissen, J. J., Hughes, T., Agis, H., Fischer, T., Verhoef, G., Shepherd, J., Saglio, G., Gratwohl, A., Nielsen, J. L., Radich, J. P., Simonsson, B., Taylor, K., Baccarani, M., So, C., Letvak, L., Larson, R. A., & IRIS Investigators. (2006). Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. New England Journal of Medicine, 355(23), 2408-2417. https://doi.org/10.1056/NEJMoa062867
- 5.Kantarjian, H., Shah, N. P., Hochhaus, A., Cortes, J., Shah, S., Ayala, M., Moiraghi, B., Shen, Z., Mayer, J., Pasquini, R., Nakamae, H., Huguet, F., Boqué, C., Chuah, C., Bleickardt, E., Bradley-Garelik, M. B., Zhu, C., Szatrowski, T., Shapiro, D., & Saglio, G. (2010). Dasatinib versus imatinib for newly diagnosed chronic-phase chronic myeloid leukemia. New England Journal of Medicine, 362(24), 2260-2270. https://doi.org/10.1056/NEJMoa1002315
- 6.Saussele, S., Richter, J., Guilhot, J., Gruber, F. X., Hjorth-Hansen, H., Almeida, A., Janssen, J. J., Mayer, J., Koskenvesa, P., Panayiotidis, P., Olsson-Strömberg, U., Martinez-Lopez, J., Rousselot, P., Vestergaard, H., Ehrencrona, H., Kairisto, V., Machová Poláková, K., Müller, M. C., Mustjoki, S., Berger, M. G., Fabarius, A., Hofmann, W. K., Hochhaus, A., Pfirrmann, M., Mahon, F. X., & EURO-SKI investigators. (2018). Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. The Lancet Oncology, 19(6), 747-757. https://doi.org/10.1016/S1470-2045(18)30192-X
- 7.Therapeutic Goods Administration. (2023). Australian Register of Therapeutic Goods. Australian Government Department of Health. https://www.tga.gov.au/resources/artg
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