Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
Conditions
Keywords
Imatinib, Generic Imatinib, Leukemia, Chronic myeloid leukemia, Philadelphia chromosome-positive, Chronic phase, Observational study, Switched patients, Tyrosine kinase inhibitor
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.
Interventions
DRUGImatinib
Film coated tablet contains 400 mg imatinib (as mesilate)
Sponsors
Hikma Pharmaceuticals LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
Countries
Egypt
Outcome results
None listed