Chronic Myeloid Leukemia, Chronic Phase Clinical Trial
Official title:
Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed
Primary objectives
Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated
with Cemivil who achieve optimal response :
- Complete hematologic response (CHR) at 3 months;
- Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response
(PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months
(No Ph+ metaphases);
- Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to
ABL1 ≤0.1% on the International Scale];
Assess the safety and tolerability of Cemivil after one year of treatment, based on:
- Incidence, severity, and relationship of adverse events (AEs) to the study medication;
- Serious AEs;
- AEs leading to permanent treatment discontinuation;
- Clinically relevant changes in laboratory tests (according to laboratory reference
ranges).
Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy
"first-line patients". N=58 switched from patented imatinib to generic imatinib "switched
patients")
;
Observational Model: Cohort
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