E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009014 |
E.1.2 | Term | Chronic myeloid leukaemia (in remission) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
To investigate: 1.the variations of BCR-ABL transcript levels 2.the BCR-ABL point mutations |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |