A clinical research study evaluating the possibility to suspend the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients who have been for two different durations on Tasigna with a predifined level of molecular response.
- Conditions
- Adult patients with Ph+ chronic phase CML that have been treated with Imatinib for at least 2 years, are in CCyR, but have not achieved MR4.0 at study entry.MedDRA version: 15.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005124-15-ES
- Lead Sponsor
- ovartis Farmacéutica S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 620
Patients eligible for inclusion in this study have to meet all of the following criteria:
?Confirmed diagnosis of chronic phase Ph+ CML
?Previous first-line treatment with imatinib for a minimum of 2 years;
?Patient in complete cytogenetic response;
Additional inclusion criteria as per protocol apply.
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 758
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
Patients eligible for this study must not meet any of the following criteria:
?Previous achievement of MR4.0 at study entry;
?Previous treatment with other target cells inhibitors other than imatinib;
?Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
?Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
?Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
?History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
?Patients who have not recovered from prior surgery;
?Treatment with other investigational agents within 4 weeks of Day 1;
?Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Additional exclusion criteria as per protocol apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method