Effectiveness and Safety Study of Generic Imatinib in Chronic Myeloid Leukemia Patients in Egypt
- Conditions
- Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
- Interventions
- Registration Number
- NCT03454503
- Lead Sponsor
- Hikma Pharmaceuticals LLC
- Brief Summary
The purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP) in Egypt
- Detailed Description
An observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic Imatinib (Carcemia®) in patients with Ph+ CML who are newly diagnosed or patients who will be switched from the reference product (Glivec® ) to Carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed.
Eligible Ph+ CML patients in both cohorts will be followed up for a total of 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
First cohort (newly diagnosed patients):
- Age ≥18 years
- Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
- Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
- 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
- Written informed consent
Second cohort (switched patients):
- Age ≥18 years
- Ph+ CML patients in CP currently treated with Glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch
- 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
- Written informed consent
- CML in accelerated phase (AP) at enrollment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis
- CML in BP at enrollment
- Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description First cohort Imatinib Newly diagnosed patients Second cohort Imatinib Patients switched from reference product (Glivec® )
- Primary Outcome Measures
Name Time Method Proportion of patients who achieve and maintain major molecular response (MMR) 12 months Major molecular response (MMR) is measured using real-time quantitative polymerase chain reaction (RQ-PCR) test and is defined as BCR-ABL1 ≤ 0.1%
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) and serious adverse events (SAEs) to generic Imatinib (Carcemia®) 18 months Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Progression free survival (PFS) 18 months Proportion of CML patients who will not experience disease progression from enrollment to 18 months study endpoint.
Event free survival (EFS) 18 months Proportion of CML patients who will not experience event from enrollment to 18 months study endpoint
Survival without blastic phase (BP) 18 months Proportion of CML patients who will not experience blastic phase (BP) from enrollment to 18 months study endpoint.
Overall survival (OS) 18 months Proportion of CML patients who will not die till 18 months study endpoint.
Complete cytogenetic response (CCgR) 12 months Proportion of CML patients who will achieve no Ph+ metaphases at 12 months study endpoint by conventional cytogenetics and/or FISH test.
Complete molecular response (CMR) 12 months Proportion of CML patients who will achieve undetectable BCR-ABL mRNA transcripts by RQ-PCR test in two consecutive blood samples of adequate quality.
Health-Related Quality of Life (HRQoL) 18 months Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
Treatment compliance on generic Imatinib 18 months Evaluated by identifying the frequency of not taking the medications as prescribed and the reasons. The decision on non-compliance is based on the treating physician's judgment.
Trial Locations
- Locations (1)
National Cancer Institute (NCI)
🇪🇬Cairo, Egypt