Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response
Leukemia, Chronic Myeloid
About this trial
This is an interventional treatment trial for Leukemia, Chronic Myeloid
Eligibility Criteria
Inclusion Criteria:
- Patients with a confirmed diagnosis of Ph+ CML in CP
- Age ≥ 60 years old
- Stable MR3.0/ MR4.0 after at least 2 years of treatment with standard (daily administration) IM, NIL, or DAS therapy; the stability of molecular response will be documented by at least 3 consecutive molecular analyses over the last 12 months.
- Having completed the QoL baseline evaluation (i.e., before randomization)
- Written informed consent prior to any study procedures
Exclusion Criteria:
- Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP previously treated (i.e. IFNalpha+/- low dose Ara-C, Hydroxurea, allogeneic stem cell transplantation, etc)
- Age < 60 years old
- Less than 2 years of treatment with standard (continuous administration) IM, NIL or DAS therapy
3. Absence of stable MR3.0/MR4.0 as documented by at least 3 consecutive molecular analyses over the last 12 months 4. No written informed consent prior to any study procedures. 5. Having any kind of psychiatric disorder or major cognitive dysfunction hampering a QoL evaluation (as judged by the physician).
Sites / Locations
- Policlinico Universitario di MilanoRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Fixed INTERIM TKI
Progressive INTERIM TKI
Intervention: "fixed" intermittent administration (one month ON/one month OFF) of TKIs (imatinib, nilotinib, dasatinib)
Intervention: "progressive" intermittent administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for the 2nd year; one month ON/three months OFF for the 3rd year) (imatinib, nilotinib, dasatinib)