HALF: Prospective multi-centre phase II clinical trial evaluating the efficacy and safety of tyrosine kinase inhibitors discontinuation after two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission.
|Year of publication||2022|
|MU Faculty or unit|
|Description||Treatment-free remission (TFR) has become a new treatment goal for chronic myeloid leukemia (CML) patients. However, usually abrupt tyrosine kinase inhibitors (TKIs) therapy discontinuation has been successful only in about half of eligible patients and it can cause burdening TKI withdrawal syndrome (TWS) in about 30% of them. Moreover, any robust clinical or biological factor predictive for successful TFR has not been identified yet. On top of that, sustainable deep molecular response (DMR) as the main prerequisite for TKI discontinuation attempt is achieved only in 20-40% of patients. The majority of CML patients, therefore, need to be treated with the effective and well-tolerated drug for a long time or even life-long.|