CRESCENDO (Compliance: Role Emerges for Success in CML: Evaluation aND Optimisation): A prospective, multi-center, phase IV study to assess the compliance in patients with Philadelphia chromosome-positive (Ph+) and/or BCR-ABL-positive chronic myelogenous leukemia (CML) under long-term imatinib therapy - CRESCENDO

GMIHO mbH0 个研究点开始时间: 2010年6月21日最近更新: 2014年2月3日

适应症

试验速览

暂无简介。

•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

•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

发起方

GMIHO mbH