Patients with CML Ph+ CP that are in cytogentic response complete and stable for the last two years, treated with a Glivec daily dose MedDRA version: 9.1 Level: LLT Classification code 10009014 Term: Chronic myeloid leukaemia (in remission)
Conditions
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of Ph+ CML in CP 2. Age ≥ 65 years old 3. Stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analyses over the last 12 months 5. Karnofsky performance status >50% 6. Written informed consent prior to any study procedures being performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with Ph+ CML in acclerated/blastic phase (AP/BP), or in late CP previously treated (i.e. IFN+/- low dose Ara-C, Hydroxurea, allogeneic stem cell transplantation, etc etc.) 2. Age < 65 years old 3. No stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy as documented by 2 consecutive cytogenetic analysis over the last 12months 4. Karnofsky performance status <50% 5. No written informed consent prior to any study procedures being performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the proportion of patients who remain in CCgR with an intermittent dose of Imatinib (INTERIM) administered discontinuously, one month on / one month off, for one year;Secondary Objective: To investigate: 1.the variations of BCR-ABL transcript levels 2.the BCR-ABL point mutations;Primary end point(s): of patients who remain in CCgR with an intermittent dose of Imatinib (INTERIM) administered discontinuously, one month on / one month off, for one year | — |
Countries
Italy
Outcome results
None listed