The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.
ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI) Primary Objective: \- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI. Secondary objectives: * To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption. Tertiary objective: To evaluate the pharmacoeconomic impact of interrupting the treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.
FUNDALEU
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
RECRUITINGMolecular relapse free survival during 24 months
Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR. RQ PCR (IS) \>0.1% BCR ABL will be considered as loss of MMR
Time frame: 24 months
Treatment-free survival during 24 months
Treatment-free survival , defined as the time from the start of TKI interruption to the restart of the TKI.
Time frame: 24 months
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