The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years
2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
4. Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
5. Written informed consent
Exclusion Criteria:
1\. CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.
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Primary outcome measure(s)
Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months — 12 months Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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