CML - chronic myelogenous leukemia MedDRA version: 14.1 Level: LLT Classification code 10009700 Term: CML System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Glivec Filmtabletten
Product Name: Glivec
Product Code: STI571
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Current Sponsor code:
Sponsors
GMIHO mbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: end of study (month 12) | — |
Primary
| Measure | Time frame |
|---|---|
| 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 •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 ;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. | — |
Countries
Germany
Contacts
Public ContactCRO
CROLLL GmbH
Outcome results
None listed