Health Technology/clinical-trials

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

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4 Apr 2026

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4 min read

·clinical-trials

The 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. 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. 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. 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. 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. 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. 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. 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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