Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
In this phase III clinical randomized study, "fixed" intermittent administration (one month
ON/one month OFF) of TKIs (control arm), will be compared with "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) (experimental arm). Imatinib
(Glivec), or Nilotinib (Tasigna), or Dasatinib (Sprycel) will be given intermittently at the
same daily dose that was given daily at the time of the enrollment . Chronic phase Ph+ CML
patients in stable major molecular response (MR3.0 or MR4.0) after ≥2 years of standard
treatment with IM, NIL, or DAS will be randomized 1:1 to receive "fixed" INTERIM or
"progressive" INTERIM. Randomization will be stratified by type of TKI (IM, NIL, or DAS,) and
by depth of molecular response (MR3.0or MR4.0). The study is aimed to evaluate if a
progressive increase of intermittent treatment discontinuation until 3 months is able to
improve QoL outcomes with respect to "fixed" intermittent administration of TKIs (control
arm) and to maintain MR3.0 / MR4.0 molecular response. Patients' self reported EORTC QLQ-C30
outcome measure will be assessed throughout the three years follow up period. The QoL results
in this trial will be presented in accordance with high methodological quality criteria for
documenting patient-reported outcomes (PRO) data in RCTs, including the CONSORT PRO
recommendations. Furthermore, the study could give additional clinical and biological
information to optimize TKIs therapy in elderly.
Phase:
Phase 3
Details
Lead Sponsor:
Azienda Ospedaliera Spedali Civili di Brescia Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia