E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CML - chronic myelogenous leukemia |
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E.1.1.1 | Medical condition in easily understood language |
chronic myelogenous leukemia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009700 |
E.1.2 | Term | CML |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess patient’s compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention. |
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E.2.2 | Secondary objectives of the trial |
•to correlate the compliance assessed by pill count (conventional pill count and pill count using SmartBlister in selected centers) with the results obtained by the questionnaires and interviews
•to monitor the efficacy of imatinib as assessed by PCR testing (BCR-ABL load, % IS)
•to correlate the compliance with the efficacy as assessed by PCR testing
•to correlate the compliance with imatinib blood levels during imatinib treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Adult (> 18 years) CML patients in the chronic phase
•Medical History of cytogenetically confirmed CML-CP by the presence of the Philadelphia chromosome on bone marrow aspirates (a minimum of 20 metaphases is required; FISH cannot be used); Philadelphia chromosome negative, but BCR-ABL positive CML patients should not be excluded
•ECOG performance status of < 2
•Imatinib treatment for at least 1 year before study entry and showing CCyR or MMR
•Prior treatment with chemotherapeutics such as hydroxyurea or interferon-alpha is allowed
•Prior periods of accelerated phases are allowed
•Negative pregnancy test for female patients of childbearing potential within 7 days before initiation of study drug
•Ability to understand and willingness to sign a written informed consent document prior to any study related screening procedures
•Patient must agree to provide his/her phone-number to the external, neutral institution
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E.4 | Principal exclusion criteria |
•Patients with prior blast crisis or stem cell transplantation
•Patients with severe medical condition(s) that in the discretion of the investigator prohibits participation in the study (e.g., clinically significant heart diseases, uncontrolled diabetes, active or uncontrolled infection, impaired gastrointestinal function/diseases)
•Treatment with drugs or substances, especially those known to modify the cytochrome P450 activity, should be either discontinued or exchanged by different medication (see link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.)
•Pregnant or breastfeeding women
•Male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the compliance of the patients (as the number of pills taken in relation to the number of pills prescribed in %). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
compliance assessed by pill count vs subjective compliance assessed by questionnaires and interviews
efficacy of imatinib (PCR testing; BCR-ABL load, %IS)
efficacy of imatinib (PCR testing; BCR-ABL load, %IS) according to compliance
Imatinib blood levels during treatment according to compliance |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 23 |
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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |