Phase II explorative study of intermittent Imatinib (IM) treatment (INTERIM) in elderly patients with Ph+ chronic myeloid leukemia (CML) who achieved a stable complete cytogenetic response (CCgR) with standard IM therapy - INTERIM 0407
- Conditions
- Patients with CML Ph+ CP that are in cytogentic response complete and stable for the last two years, treated with a Glivec daily doseMedDRA version: 9.1Level: LLTClassification code 10009014Term: Chronic myeloid leukaemia (in remission)
- Registration Number
- EUCTR2007-005102-42-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method