CRESCENDO: comparison of two different methods for patient assistance regarding compliance, i. e. use of patient diary or CML infopackage with CML patients under long-term imatinib therapy.

• Conditions: CML - chronic myelogenous leukemia; MedDRA version: 14.1Level: LLTClassification code 10009700Term: CMLSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-018339-16-DE
• Lead Sponsor: GMIHO mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-21
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: •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<br>•to monitor the efficacy of imatinib as assessed by PCR testing (BCR-ABL load, % IS)<br>•to correlate the compliance with the efficacy as assessed by PCR testing<br>•to correlate the compliance with imatinib blood levels during imatinib treatment<br>;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 %).;Timepoint(s) of evaluation of this end point: end of study (month 12);Main Objective: To assess patient’s compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): compliance assessed by pill count vs subjective compliance assessed by questionnaires and interviews<br>efficacy of imatinib (PCR testing; BCR-ABL load, %IS)<br>efficacy of imatinib (PCR testing; BCR-ABL load, %IS) according to compliance<br>Imatinib blood levels during treatment according to compliance;Timepoint(s) of evaluation of this end point: end of study (month 12)